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CANADIAN VIGOUR CENTRE
Inside this
issue:
CVC is proud to be a
University of Alberta Centre
Bridging hearts and minds to enhance
cardiovascular care
www.vigour.ualberta.ca
Letter -
PW Armstrong
1
Trial Updates 2-6
Monitoring 6
Biostatistics 7
CVC
Publications and Abstracts
7-8
Winter 2013 Volume 17, No. 3
A foot of fresh snow blankets the ground and the days grow shorter as the winter solstice approaches in northern
Alberta. Now that Canadian - and more recently American - Thanksgiving holidays are in the rear view mirror and
Christmas approaches, it is a fine time to reflect on our many blessings. The origins of Canadian Thanksgiving,
celebrated on the second Monday of October, can be traced to the freezing and stormy sail of Martin Frobisher
who, after finally anchoring in Frobisher Bay off Baffin Island, was prompted by his accompanying minister to be
“thankful to God for their strange and miraculous deliverance in those so dangerous places”. By contrast the first
Thanksgiving in the United States, celebrated on the third Thursday of November, is generally attributed to the
pilgrim feast in Plymouth Massachusetts in 1621 after the first harvest that followed a particularly difficult winter.
Canada and the United States share many things. When John Kennedy addressed the Canadian parliament a few
months after he was elected President of the United States in 1961, he reflected that “Geography has made us
neighbors, history has made us friends, economics has made us partners, necessity has made us allies. What unites
us is far greater than that which divides us.”
Sometimes amidst the challenges associated with achieving our academic mission and pushing the boundaries to
acquire new and clinically relevant knowledge, it is tempting to become dispirited. It is at just those times that it is
crucial to recall that our major limitations are few and largely related to the quality of our ideas, the resourcefulness
and skill with which we develop and communicate them, and the passion and tenacity necessary to realize them.
The spirit of collaboration shared across the longest unpatrolled border in the world separating Canada and the US
is alive and well, as it is with many of our global partners around the world. The sharing of our ideas through
clinical trials, registries and population health outcomes data inform us while at the same time generating a more
lucid path forward. The recruitment of young people to the cause, supporting their training in other academic
centres and countries, as well as the enrichment provided by academic visits to our different institutions is a most
welcome signal of this collaborative spirit. In just the last 60 days, I have had splendid learning experiences and the
great privilege of working with friends and colleagues in Montreal, Quebec, Sydney, Australia, the University of
Leuven in Belgium, Dallas, Texas and Stanford University in California.
Within this issue of the Chronicle, the collaborative spirit and opportunities are reflective of an abundant harvest
and we are thankful to our many partners that enable this. That said, I wish to particularly highlight the outstanding
work of Warren Cantor and his study coordinator Kim Robbins at the Southlake Medical Centre in Ontario and
sincerely thank them for energizing our investigation of a novel anticoagulation system in the Regulate PCI Trial with
great velocity. More details on the trial and their team are featured in this issue of the Chronicle.
As we reflect on our many blessings at this hinge point in the calendar, it is good to recall that “to whom much is
given, much will be required”. From our team at the Canadian VIGOUR Centre to yours, we genuinely extend our
warmest wishes for a Merry Christmas, Happy Hanukkah and enjoyable holiday season. We hope it finds you
amidst the warmth of family and friends, replenishing your energy and spirits and preparing to seize the novel
opportunities afforded by the dawn of the new year ahead.
Letter from Dr. Paul Armstrong:
With kind regards,
Paul W. Armstrong
Page 2 THE CANADIAN CARDIAC CHRONICLE
IMPROVE-IT
As we approach 2014, the year that the IMPROVE
IT trial expects to reach the protocol-defined number of clinical endpoints, the focus becomes
data cleanliness, in addition to patient retention. On the patient retention front, the Participant
Newsletter (Memo #407B) was sent to sites in early September. Please forward your REB
approval letters to CVC. The data cleanliness effort began with Memo #408 (“New Expedited
Queries to be issued”) in late August, and continues with the Data Cleaning Initiative which
began in late October.
We continue to work on answering outstanding
AE QC queries. Remember, if an AE is not an endpoint, then the AE must clearly state this.
Emails have been sent to those sites that either have queries that are still open, or queries that
were answered incorrectly. Your cooperation in addressing these important “AE QC” data queries
within 10 days is appreciated.
Data Cleaning Initiative: a targeted data sweep has
been issued from October 21 - December 13, 2013 with the goal to have all data from study
visits entered into INFORM by the end of 2013. The data sweep will target all late visits, missing
data, and opened/answered critical queries that are more than 10 days late. As always, we appreciate
your assistance, and time, on these initiatives!
Data Clean Up – Commendations to ALL of the
IMPROVE IT CVC sites on achieving >/= 97%!!! As of November 13 20 sites have achieved 100%
monitor clean data, and another 11 sites have achieved 98-99% monitor clean data (this is a
record for the year!!)
As a reminder, an email was sent to all sites in
September regarding the PR Status Reports for study drug. These two reports are to be printed
and filed in your Investigator Site File (in the Drug Accountability Binder). The monitors will be
verifying that these reports are on site and filed accordingly.
CEC Adjudicated Events – please remember to submit any outstanding (de-identified) source
documents to the TIMI CEC.
For further information, please contact Clinical
Trial Project Lead Jodi Parrotta at 1-800-707-9098 (ext. 3) or by email at [email protected].
ODYSSEY OUTCOMES
ODYSSEY Outcomes is one of 12 Phase III trials
that have been initiated as part of the more than 23,000 patient ODYSSEY clinical trial program.
The first Phase III study (ODYSSEY MONO) to report data from the ODYSSEY clinical trial
program showed that it met its primary efficacy endpoint: the mean LDL-C reduction from
baseline to week 24, was significantly greater in patients randomized to alirocumab, as compared
to patients randomized to Ezetimibe (47.2% vs. 15.6%, p<0.0001).
The ODYSSEY Outcomes trial is well underway with over 1400 patients randomized globally. In
Canada, 28 sites have been activated with more than 80 patients screened and 20 randomized.
We are looking forward to activating the remainder of our sites over the coming months
with further increase in screening and recruitment efforts at all sites in Canada.
Don’t forget to complete all your training and regulatory documents while you are waiting on
contracts and ethics! For those sites that have
now screened and/or randomized a patient, don’t
forget to complete your CRF’s and answer any open queries. Please keep an eye out for key trial
updates and Canadian newsletters sent out to your site throughout the trial.
The upcoming Protocol Amendment 2—pending FDA acceptance—is expected soon. We tentatively
plan to submit to Health Canada before end of the year with approval in early 2014. We anticipate
this will help to boost recruitment at participating sites in the coming months. More details will be
forthcoming in the near future.
We’ve had some recent changes to the ODYSSEY
team at CVC and Robert Evans has now transitioned off of the project. We are still
recruiting a few final sites for this study so if you are interested in hearing more about ODYSSEY or
have questions regarding the trial, please contact Clinical Trial Project Lead Amanda Carapellucci at
1-800-707-9098 (ext. 2) or by email at [email protected] or Paula Priest
(ext. 9) or [email protected].
IMProved Reduction of
Outcomes: Vytorin Efficacy International Trial
Sponsored by Merck & Co. Inc., (previously Schering-
Plough Research Institute) this trial is a multicenter,
double-blind, randomized study to establish the
clinical benefit and safety of Vytorin (ezetimibe/
simvastatin Tablet) vs. simvastatin monotherapy in
high-risk patients presenting with acute
coronary syndrome.
ClinicalTrials.gov
Identifier: NCT00202878
Sponsored by Sanofi-
aventis Recherche & Développement this is a
randomized, double-blind, placebo-controlled, parallel
-group study to evaluate the effect of SAR236553/
REGN727 on the occurrence of cardiovascu-
lar events in patients who have recently experienced
an Acute Coronary Syndrome.
ClinicalTrials.gov
Identifier: NCT01663402
Page 3 Volume 17, No. 3
STABILITY
In mid November, GSK released the top-line
results from this study which showed that the study did not meet its primary endpoint of time to
first occurrence of any major adverse cardiovascular event (MACE). This is a rich set of
data which will be closely analyzed in the coming months and we look forward to sharing the full
results in 2014. We appreciate all the hard work from our 32 Canadian sites and all the patients
who contributed to this study over the last five years.
As we clean up and finalize the study files, please make sure to send a copy of your ethics
REGULATE PCI
The REGULATE-PCI held its first North American
Investigator Meeting (IM) in October in Chicago. It was a great opportunity to meet face-to-face
with many of our sites and learn about the protocol and overall study. If you were unable to
attend that meeting, the next North American IM will be occurring in late February 2014 (location
to be determined).
The study is now underway across North America
with over 90 patients enrolled at nine sites. In Canada, Dr. Cantor’s site continues to excel! To
date, they have enrolled 30 patients, and remain the highest global enroller – a title they have held
for nearly two months! Congratulations to Dr. Cantor and his team!! They are a shining
example of what five engaged interventionalists and one keen study coordinator (Kim Robbins)
can accomplish together (see picture inset)!
In November, two more sites were activated in
Canada: Dr. Fung in Vancouver, BC and Dr. Mehta in Hamilton, ON. We look forward to
these two sites enrolling their first patients in the coming weeks.
We will be working hard to get the remainder of
our sites activated in the next couple of months and look forward to having all of our sites
recruiting early in the new year.
For further information, or if you are interested in
participating, please contact Clinical Trial Project Lead, Jodi Parrotta at 1-800-707-9098 (ext. 3) or
by email at [email protected].
PROACT
The Edmonton Emergency Medical Services (EMS)
teams continue to actively recruit patients, with over 180 patients now enrolled into the study.
We appreciate their continued hard work and commitment to this study.
From L to R: Dr Cantor, Dr Miner, Kim, Dr Plante and
Dr Prabhakar (missing Dr Goldman)
STabilisation of
Atherosclerotic plaque By Initiation of darapLadIb
TherapY
Sponsored by Glaxo
SmithKline, this trial is a randomized, placebo-
controlled, double-blind, parallel group, multicenter,
event-driven clinical outcomes study of
darapladib versus placebo in subjects with chronic
coronary heart disease to compare the incidence of
major adverse cardiovascu-lar events.
ClinicalTrials.gov Identifier: NCT00799903
PROACT Providing Rapid Out of
Hospital Acute Cardiovascular Treatment
An Edmonton-region local
initiative sponsored by the University Hospital
Foundation and the Mazankowski Alberta
Heart Institute. Additional support for point of care
meters provided by Alere Inc.
ClinicalTrials.gov
Identifier: NCT01634425
Sponsored by Regado
Biosciences Inc. this is a randomized, open-label,
multi-center, active-controlled, parallel group
study to determine the efficacy and safety of the
REG1 Anticoagulation System Compared to
Bivalirudin in Patients Undergoing Percutaneous
Coronary Intervention
Clinical trials.gov Identifier: NCT01848106
submission and acknowledgement of study closure
letters as well and your FIDS B forms for end of study to us at the Canadian VIGOUR Centre. As
you start to think about archiving your study files, please remember that all study related documents
will need to be archived for 25 years per Health Canada regulations.
If you have any questions or require additional information, please contact Assistant Director,
Clinical Trials, Tracy Temple @ 1-800-707-9098 (ext. 5) or via email at [email protected].
Keep up the great work!
The 2011/2012 phase of the study was presented as a Late Breaking Trial at the Canadian
Cardiovascular Congress in Montreal in October and there was also a Poster Presentation of the
study methods and baseline characteristics - “Providing Rapid Out Of Hospital Acute
Cardiovascular Treatment: PROACT 3”.
For further information please contact Paula Priest
at 1-800-707-9098 (ext. 9) or email at [email protected].
THE CANADIAN CARDIAC CHRONICLE Page 4
AEGIS-I
AEGIS-I is a new Phase 2 study investigating the
safety and tolerability of multiple dose administration of CSL112 in subjects post acute
myocardial infarction. CSL112 is an intravenous apo lipoprotein A-I (apoA-I), purified from human
plasma and reconstituted to form HDL particles. It has shown promise in earlier phase 1 and 2
studies with its ability to rapidly remove cholesterol from atherosclerotic plaque.
We are pleased to be closely collaborating with
the sponsor, CSL, in addition to the Duke Clinical Research Institute, the PERFUSE study group, the
Cleveland Clinic and Quintiles on this study. The Canadian VIGOUR Centre will be
responsible for Project/Site Management and Monitoring for all participating Canadian sites.
Initial invitations have gone out to select Canadian sites who we look forward to working through feasibility and start up with over the next few
months.
For further information, or if you are interested in
hearing more about this study, please contact Assistant Director, Clinical Trials, Tracy Temple at
1-800-707-9098 (ext. 5) or by email at [email protected].
TECOS
After a successful Rejuvenation Meeting in Boston
this November, we are confident that our TECOS sites are feeling revitalized and ready to take on
the final stages of this study! The focus of this meeting was to review the plans and expectations
surrounding the anticipated study end date in the later part of 2014.
The timelines for final patient visits and data lock once the number of adjudicated events has been
met will be tight, so there is a push for sites to enter data not only quickly but meticulously over
the next year, which will help decrease the number of queries generated by data management
and the clinical events committee. Missing data and/or data queries are expected to be cleaned
before reaching the 30 day old mark. Also, please ensure that Principal Investigators are signing SAE
casebooks promptly after the initial data entry is complete.
Congratulations to the following sites with outstanding data items < 30 days!
Dr. Woo & Dixie Hak
Dr. Kaiser & Laura Lee Magennis
Dr. Dumas & Sylvie Gauthier
Dr. Garceau & Lise Mercier
Dr. Yale & Mylene Roy
Dr. Mereu & Bonnie Woloschuk
Dr. Pandey & Sandra Clarus
Dr. Saunders & Lori Richert
Dr. Huynh & Linda Perkins
Dr. Weisnagel & Valerie-Eve Julien
Dr. Sigalas & Darlene Hutton
For any patients that have permanently discontinued study drug or have withdrawn
consent for participation in the study, it is crucial that sites are maintaining the appropriate logs and
worksheets related to these events and are submitting them to CVC on a regular basis. The
Project Team must enter detailed data for each of these patients into a special section of Inform and
we cannot do this without your help!
A friendly reminder to please review your
contracts and submit all current invoices to CVC so that you are reimbursed in a timely manner and
there is not a frantic rush to get these processed during study close-out.
Lyndsey Garritty will be transitioning off the project in December as she prepares for an
upcoming maternity leave. We are currently working on shifting TECOS to Robert Evans, who
some of you may have worked with on the ODYSSEY Outcomes study.
For further information or questions, please contact Clinical Trial Project Lead, Lyndsey
Garritty at 1-800-707-9098 (ext. 4) or via email at [email protected] or Robert Evans
(ext. 1) or [email protected].
Sponsored by Merck & Co.
Inc., TECOS is a Randomized, Placebo
Controlled Clinical Trial to Evaluate Cardiovascular
Outcomes after Treatment with Sitagliptin in Patients
with Type 2 Diabetes Mellitus and Inadequate
Glycemic Control.
ClinicalTrials.gov Identifier: NCT00790205
Sponsored by CSL Behring
LLC, this study is a Phase 2b, multicenter,
randomized, placebo-controlled, dose-ranging
study to investigate the safety and tolerability of
multiple dose administra-tion of CSL112 in subjects
with acute myocardial infarction.
Volume 17, No. 3
SODIUM-HF
Based on the success of the SODIUM-HF pilot,
Phase III of the SODIUM-HF trial aims to evaluate the long-term effects of a low-sodium containing
diet compared to Usual Care in over 1,000 patients with heart failure.
SODIUM-HF is just getting started with an anticipated 15 sites across Canada expected to
participate. Initial invitations have gone out with an overwhelming response to date! Regulatory
documents are being reviewed at several sites and
we plan to activate our first site in early 2014. If
you are a participating site, we look forward to working with you to make this trial a success.
If you are interested in participating in SODIUM-
HF or would like further information, please
contact Clinical Trial Project Lead Melisa Spaling at
780-492-8476 or via email at [email protected]
GUIDE-IT is well under way in Canada with our first two patients enrolled and 4 of our planned 6
sites activated and working hard at screening patients. In North America there are now over
150 patients enrolled with most sites now activat-ed.
Congratulations to Dr. Patricia Campbell, Kim Ronak & Sheilah Heal at the University of Calgary/
Foothills Hospital for enrolling the first two Cana-dian GUIDE-IT patients. Congratulations to our
other active sites:
Dr. Justin Ezekowitz & Quentin
Kushnerik – University of Alberta Hospital/Mazankowksi Alberta Heart Institute,
Edmonton
Dr. Robert McKelvie, Barb Miller & Lydia Morrow – Hamilton Health Sciences,
Hamilton
Dr. Mustafa Toma, Liz Grieve & Cynthia Van Hoof – St. Paul’s Hospital, Vancouver
As screening and enrollment activities heat up, please ensure that you are reviewing your patient
recruitment plans and revising these as needed. CVC and DCRI will be requesting your updated
plans on a regular basis. Screening logs should be sent to CVC every Thursday. These logs are very
helpful and assist the Project Team in identifying enrollment challenges.
Thank you to each of our sites for working hard
on obtaining Protocol Amendment 1 approval so quickly. The inclusion/exclusion revisions in this
amendment should provide for a wider range of
GUIDE-IT
patient eligibility. For those enrolling sites please
ensure that source documents are being sent in and Inform data entered within 5 business days of
each visit. Please refer to the GUIDE-IT website for the most current versions of the eCRF
Instructions, study documents, training items, etc. The website also houses a Frequently Asked
Questions document that is updated continuously.
Monthly GUIDE-IT teleconferences have now
been scheduled for both PI’s and Study Coordinators to attend, which will provide an
excellent venue to gather new screening ideas, understand some of the challenges to enrollment
and possible solutions, and to also ask any questions you may have about the study. Please
check your email or contact CVC for scheduled dates and times.
Thank you to all of our GUIDE-IT sites for your commitment to participate in this important heart
failure study. We are looking forward to working with each of you closely to make this trial a
success!
Lyndsey Garritty will be transitioning off the
project throughout December as she prepares for an upcoming maternity leave. We are pleased to
have Melisa Spaling, assuming the role of Project Lead on this study in the coming weeks. If you
have not already connected with Melisa she will be in touch with all participating sites this month.
For further information, please contact Melisa Spaling, Clinical Trial Project Lead at 780-492-8476 or via email at [email protected]
In collaboration with DCRI
(Duke Clinical Research Institute) and Roche
GUIDE-IT is a prospective, randomized 1:1, multi-
centre clinical trial GUIDing Evidence Based Therapy
Using Biomarker Intensified Treatment in Heart Failure
ClinicalTrials.gov
Identifier: NCT01685840
Funded by the Canadian
Institute of Health Research
(CIHR), SODIUM-HF is a
multicenter, randomized,
open-label Study of Dietary
Intervention Under 100
MMOL in Heart Failure.
SODIUM-HF
Page 5
Page 6 THE CANADIAN CARDIAC CHRONICLE
EXSCEL
The EXSCEL trial is moving right along with over
8300 subjects enrolled globally. Our 24 Canadian sites have been able to contribute 330 subjects,
and that number continues to steadily increase. With the planned expansion and increase in total
enrollment for the EXSCEL trial, your continued support will be critical to the success of the trial!
We would like to congratulate one of our most recently activated sites, Dr. R. Kuritzky and his
staff at Fraser Clinical Trials, who quickly enrolled 13 patients in 4 months. Currently they hold the
top spot for ratio of patients enrolled per month! Additionally we would like to acknowledge our
other top enrolling sites for the months of August 2013 through to October 2013:
Institut Universitaire de Cardiologie et de Pneumologie de Québec, PI – Dr. F. Dubé,
SC – Marilène Bolduc
Surrey Memorial Hospital – Cardiology Clinical Trials, PI – Dr. S. Cheung, SC – Tracy
Cleveland
The Ottawa Hospital, PI – Dr. H. Lochnan, SC – Denise DeCurtis
A big thank you to these sites and to all sites who continue to actively screen and enroll patients -
your efforts and enthusiasm for the EXSCEL trial are greatly appreciated!
As your excellent screening and enrollment work
continues, we will begin to take a closer look at our retention metrics. So far our Canadian sites
have done a fantastic job of retaining patients in the study and we hope to see that trend continue.
Every patient is important – so please ensure you contact the EXSCEL study Hotline to discuss all
cases of patients coming off study drug or potentially withdrawing consent. If you have any
questions or concerns, we encourage you to contact your project lead to discuss them and to
review all the alternative options that are available to your patients.
The Amendment 4 transition is currently 96% complete for Canada. This would not have been
possible without the continued cooperation of each of our sites – thank you to each of you! We
are excited for the upcoming changes from our new sponsor and we look forward to seeing many
of you at the EXSCEL North American Rejuvenation Meeting, scheduled for January 2014!
For further information or if you are interested in participating in this trial, please contact Clinical
Trial Project Lead, Amanda Carapellucci at 1-800-707-9098 (Ext 2) or by email at
[email protected] or Diane Camara at 1-800-725-6585 or by email at
Exenatide Study of
Cardiovascular Event Lowering
Sponsored by Amylin
Pharmaceuticals, Inc. this trial is a pragmatic, long
term, placebo-controlled, double-blinded trial which
seeks to characterize the effects of exenatide once
weekly on cardiovascular(CV) -related outcomes in
patients with type 2 diabetes when added to
the current usual care for glycemic control in a
standard care setting.
ClinicalTrials.gov
Identifier: NCT01144338
MONITORING
In our last issue we highlighted several audit tips
and thought we would continue them into this issue as we feel that sharing these will help us all
to be better prepared for that next audit.
Ensure you have, at minimum, Standard
Operating Procedures (SOPs) on the consent process, AE/SAE documentation and submission
to sponsor/ethics, study drug storage, dispensing and return, screening and eligibility of subjects,
source documentation, and record retention. And don’t forget that every staff member should
be trained on the site SOPs and the training documented.
Consenting of subjects should be done per your
site SOP. The subject should print, sign and date the consent and initial each page (if
applicable. The date of the consent should be in the format that has been approved by the REB.
For example if the REB wants the date to be documented as DD/MM/YYYY, then the date
should be written as 10/09/2013 to note that it is 10th day of September 2013. The study team
member who administers the consent should review that the consent is properly completed
including the format of the date. The consent
process with each patient should be
documented as per your SOP whether you use a consent process checklist or it is hand written
in the progress note. Any consent amendments should be provided to the subject at the next
clinic visit after receiving ethics approval.
Ensure all site staff are listed on the delegation log and that the responsibilities of each staff member are assigned by the principal
investigator (PI) who should sign, initial, and date each entry. While we all know how important
study coordinators (SC) are in running a trial remember they cannot be assigned the following
responsibilities: (1) eligibility of subjects and (2) assessment of AE/SAE’s. The SC can screen
subjects and collect AE/SAE’s. If the delegation log has codes and there are no separate codes
for SC to screen or collect information you can always use “other” or add additional codes
listing what the responsibility is. Finally, any deletion or additions to the log are to be signed/
initialed and dated by the PI not the SC or other site staff.
For monitoring related questions please contact
Lead CRA, Halina Nawrocki at 1-905-896-7292 or by email at [email protected].
Page 7 Volume 17, No. 3
2013 International Year of Statistics: How Statistics Impacts You
While “celebrating” and “statistics” would not
often be found together in a sentence in common conversation, we predict that there has been a
significant increase in its frequency in 2013. This year marks the International Year of Statistics
with its aim of increasing awareness of the impact of statistics across many facets of our lives. Those
of us in clinical research, however, have recognized its invaluable contribution for some
time. This art and science of learning from (or making sense out of) data may seem daunting to
some, but for those of us who have made it our career, we take our role seriously.
Being the bridge between the collected data and answering clinical questions is central to what we
do. Involving those with such expertise, and doing so early on, goes a long way in terms of the
credibility of clinical research. This has been a long-standing commitment at the CVC. Our
biostatistics team is made up of applied methodologists, with backgrounds in
epidemiology, mathematics, measurement, and statistics. We have acquired experience in large
administrative, population-based cohorts and clinical trial databases, and in disease states
including acute coronary syndromes, heart failure, and diabetes. Based on formal training and
experience, we can optimize many aspects of
clinical research, from study design to analysis, and to the interpretation and conclusions of
results. With the other members of the clinical research team, we help to achieve the equilibrium
between statistical and clinical significance.
We also have a unique opportunity to mentor the
next generation of clinical investigators. Conveying an appreciation for statistics is important to the
sustainability and advancement of clinical research. So too is the development and/or application of
novel statistical techniques. At the CVC, we have used a variety of advanced techniques including
multilevel modeling, dynamic risk modeling, gap-time modeling and weighted composite
endpoints to address novel clinical questions.
As 2013 draws to a close, so too does this formal
celebration of statistics. However, as the digital platform (and collection of data) continues to
broaden and pressures increase to conduct more efficient clinical research, the ability to translate
raw data into meaningful information will continue to increase in value. The party must, and will, go
on.
CVC
HOLIDAY
CLOSURE
December 24, 2013
to
January 1, 2014
Should any urgent
issues arise, we
encourage you to call
the designated
helpline for your
study
CVC’s main
voicemail will be
checked daily
throughout the
closure to address
any important
study-related issues.
CVC wishes you and
your families the
happiest of holidays.
Selected CVC Presentations and Publications Since Last Issue
Publications
Armstrong PW, Califf RM. Data and Safety Monitoring Boards: Academic Credit Where Credit Is Due? JAMA 2013; 301:1563-4. http://dx
.doi.org/10.1001/jama.2013.280383
Dianati Maleki N, Stocke K, Zheng Y, Westerhout CM, Fu Y, Chaitman BR, Awad A, Armstrong PW.
An assessment of ST-segment measurement variability between two core electrocardiogram
laboratories. Journal of Electrocardiography In press.
Whellan D, Tricoci P, Chen E, Huang Z, Leibowitz
D, Pascal Vranckx P, Marhefka G, Held C, Nicolau J, Storey RF, Ruzyllo W, Huber K, Sinnaeve P,
Weiss AT, Déry J-P, Moliterno D, Van de Werf F, Aylward P, White, H, Armstrong P, Wallentin L,
Strony J, Harrington RA, Mahaffey KW. Vorapaxar in Acute Coronary Syndrome Patients Undergoing
Coronary Artery Bypass Graft Surgery: Subgroup Analysis from the TRACER Trial. J Am Coll Cardiol.
E pub ahead of print pii: S0735-1097(13)06018-X. 10.1016/j.jacc.2013.10.048
Stewart R, Claes Held C, Brown R, Vedin O, Hag-
strom E, Lonn E, Armstrong P, Granger CB, Hoch-man J, Davies R, Soffer J, Wallentin L, White H.
Physical activity in patients with stable coronary heart disease: an international perspective.. Eur
Heart J in press http://dx.doi.org/10.1093eurheartj/eht258.
Toma M, Ezekowitz JA, Bakal JA, O’Connor CM, Hernandez AF, Sardar MR, Zolty R, Massie BM,
Swedberg K, Armstrong PW, Starling RC. The relationship between left ventricular ejection
fraction and mortality in patients with acute heart failure: Insights from the ASCEND-HF Trial. Eur J
Heart Fail in press.
Hess CN, Schulte PJ, Newby LK, Steg PG, Dalby
AJ, Schweiger MJ, Lewis BS, Armstrong PW, Califf RM, van de Werf F, Harrington RA. Duration of
eptifibatide infusion after percutaneous coronary intervention and outcomes among high-risk
patients with non-ST-segment elevation acute coronary syndrome: insights from EARLY ACS. Eur
Heart J Acute Cardiovasc Care. 2013; 2(3):246-55. (PMID 24222836) http://dx.doi.org/10.1177/204
8872612474922
Page 8
Publication Information
This newsletter is published
periodically as a service to
Canadian investigational sites. The
purpose is to provide information
of interest to individuals involved
in cardiovascular clinical trials
managed by the Canadian
VIGOUR Centre, University
of Alberta in Edmonton, Alberta,
Canada.
The VIGOUR (Virtual
Coordinating Centre for Global
Collaborative Cardiovascular
Research) group is an international
academic group committed to
advancing cardiovascular medicine
and enhancing patient care
worldwide. Its membership
includes: the Canadian VIGOUR
Centre (CVC), University of
Alberta, Edmonton, Alberta,
Canada; Green Lane Coordinating
Centre, Auckland, New Zealand;
National Health & Medical
Research Council – Clinical Trials
Centre, Sydney, Australia; Flinders
Medical Centre, Bedford Park,
Australia; Duke Clinical Research
Institute (DCRI), Duke University,
Durham, NC, USA; Leuven
Coordinating Centre, University
Hospital Gasthuisberg, Leuven,
Belgium; ECLA, Rosario,
Argentina, South America;
TANGO, Buenos Aires, Argentina,
South America; Uppsala Clinical
Research Centre, Uppsala, Sweden
Address for Inquiries:
2-132 Li Ka Shing Centre for Health Research Innovation
University of Alberta Edmonton, AB T6G 2E1
Canada Phone: 1-800-707-9098
Fax: (780) 492-0613 www.vigour.ualberta.ca
CANADIAN VIGOUR CENTRE
Selected CVC Presentations and Publications Since Last Issue
PW Armstrong
Kalli Belseck
Amanda Carapellucci
Robert Evans
Lyndsey Garritty
Halina Nawrocki
Jodi Parrotta
Dianne Payeur
Ellen Pyear
Carla Price
Paula Priest
Melisa Spaling
Tracy Temple
Canadian Cardiac Chronicle
Editorial Board:
Abstracts
Ezekowitz JA, Welsh RC, Weiss D, Gubbels C, Brass
N, Chan M, Keeble W, Khadour F, Knapp D, Sharma S,
Sookram SS, Tymchak W, Westerhout CM, Armstrong
PW. Providing Rapid Out Of Hospital Acute Cardio-
vascular Treatment (PRAOCT-3). Can J Cardiol 2013;
29 (10Suppl):S381-382.
Abualnaja S, Podder M, Hernandez A, McMurray JJ,
Armstrong PW, Ezekowitz JA. Does Atrial Fibrillation
Affect Outcomes In Patients Admitted With Acute
Heart Failure? Insights from the ASCEND-HF. Can J
Cardiol 2013; 29 (10 Suppl):S147-148.
Dianati-Maleki N, Van de Werf F, Goldstein P, Adgey J,
Lambert Y, Sulimov V, Rosell-Ortiz F, Gershlick AH,
Zheng Y, Armstrong PW. Incidence and Implications of
Aborted Myocardial Infarction in STREAM. Circulation
2013;128: A9297.
Dery JPP, Mahaffey K, Tricoci P, White H, Podder M,
Moliterno D, Harrington R, Chen E, Strony J, Van de
Werf F, Ziada KM, Held C, Aylward P, Armstrong PW,
Rao S. Arterial access site and outcomes in patients
undergoing percutaneous coronary intervention with
or without vorapaxar. Circulation 2013;128: A10742.
Jones S, Tricoci P, Huang Z, Moliterno DJ, Harrington
RA, Sinnaeve P, Strony J, Van de Werf F, White HD,
Held C, Armstrong PW, Aylward PE, Chen E, Patel
MR, Mahaffey KW. Vorapaxar in Non–ST-Segment
Elevation Acute Coronary Syndrome
Patients with Peripheral Artery Disease: Results from
TRACER. Circulation 2013; 128: A17939.
Bernacki GM, Alexander KP, Newby LK, Yang Q,
Schulte P, White HD, Ohman EM, Mahaffey KW, Shah
BR, Giugliano RP, Armstrong PW, Harrington RA,
Tricoci P, Van de Werf F, Alexander J, Califf RM. Lopes
RD. Trends in Enrollment, Patient
Characteristics, Treatments and Outcomes of Older
Adults with Non-ST-segment Elevation Acute
Coronary Syndromes (ACS) in Clinical Trials.
Circulation 2013;128:A9904.
Armaganijan L, Lopes R, Huang Z, Tricoci P, Held C,
Van de Werf F, Armstrong PW, Aylward PE, White
HD, Moliterno DJ, Wallentin L, Chen E, Harrington
RA, Strony J, Mahaffey KW. Efficacy and Safety of Vora-
paxar in Elderly Patients with Non–ST-Segment Eleva-
tion Acute Coronary Syndrome: Insights from the
TRACER Trial. Circulation 2013;128: A13198.
Tricoci P, Chen E, Neely ML, Warner A, Wong PH,
Sinnaeve P, Wallentin L, Jennings LK, Storey RF, Ayl-
ward PE, White HD, Van de Werf F, Armstrong PW,
Held C, Valgimigli M, Harrington RA, Strony J, Mahaffey
KW, Moliterno DJ. CYP2C19
Polymorphism and PON-1 Activity in NSTE ACS: Vora-
paxar Effect in Relation to Clopidogrel
Metabolism in the TRACER Trial. Circulation 2013;128:
A17658.
Bagai A, Huang Z, Lokhnygina Y, Harrington RA, Arm-
strong PW, Strony J, Chen E, White HD, Held C, Van
de Werf F, Wallentin L, Tricoci P, Mahaffey KW. Dif-
ferential Prognostic Implications of Peak Troponin
Level in Acute Coronary Syndrome Treated With and
Without Revascularization
Circulation 2013;128:A14033.
Halim S, Yang Q, Schulte P, Hochman J, Melloni C,
Mahaffey KW, Moliterno DJ, Harrington RA, White
HD, Armstrong PW, Ohman EM, Van de Werf F, Giu-
gliano RP; Newby LK. Evolution of Differences in
Women and Men with Non-ST-Segment
Elevation Acute Coronary Syndromes: Insights from
Clinical Trials over 15 years. Circulation 2013; 128:
A15834.
Welsh RC, Van de Werf F, Goldstein P, Gershlick AH,
Wilcox R, Danays T, Bluhmki E, Westerhout CM,
Armstrong PW. Impact of Rescue/Urgent
Angiography on Outcomes of ST-Elevation
Myocardial Infarction: Insights from STREAM.
Circulation 2013;128:A17925.
Clemmensen P, Roe MT, Hochman JS, Cyr DD, Neely
ML, McGuire DK, Cornel JH, Huber K,
Zamoryakhin D, White HD, Armstrong PW, Fox KA,
Prabhakaran D, Ohman EM. Outcomes in Women
Compared With Men in Patients With Unstable Angi-
na/Non-ST-Segment Elevation
Myocardial Infarction Managed Without
Revascularization: Insights From the TRILOGY ACS
Trial. Circulation 2013;128:A12130.
Lopes RD, Neely B, Ohman EM, Ardissino D, Hamm
C, Goodman SG, Bhatt DL, Brown EB, White HD,
Prabhakaran D, Martinez F, Nicolau JC, Fox KA, Arm-
strong PW, Roe MT. Timing, Profile, and Predictors of
Spontaneous Myocardial
Infarction Following a Non-ST-Segment Elevation
Acute Coronary Syndrome Event: Insights From the
TRILOGY-ACS Trial. Circulation.2013;128:A14972.
CVC gratefully acknowledges funding from the following:
Alere Inc.
Amylin Pharmaceuticals, LLC
CSL Behring LLC
GlaxoSmithKline Inc.
Hoffmann-La Roche
Merck & Co., Inc.
Regado Biosciences Inc.
Sanofi-aventis Recherche & Développement
Canadian Institute of Health Research
Mazankowski Alberta Heart Institute
University Hospital Foundation