Clarify Slide Set

8/13/2019 Clarify Slide Set

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The management of outpatients with stablecoronary artery disease in clinical practice



Need for contemporary data instable CAD

Data from randomized clinical trials often have limitedexternal validity (generalizability)

highly selected patient populations

often limited to specific geographic settings

often limited to pts with angina or with acute coronarysyndrome

most data pertain to hospitalized patients

many studies antedate the advent of modernprescriptions

In addition, there is a lack data on heart rate actuallyachieved in practice and its relation to outcomes

CAD: coronary artery disease



An international, prospective, observational

longitudinal registry in outpatients with stable CAD

The population of the CLARIFY will cover the entire

spectrum of the outpatients with CAD

5 years follow-up

Worldwide contemporary registry inoutpatients with stable CAD




Europe

Americas

Argentina

Brazil

Canada

Mexico

West Indies

39 countries

Asia

China

Korea

Malaysia

Singapore

Thailand

Middle East & Africa

Gulf Countries

Saudi Arabia

South Africa

Australia

Slovakia

Slovenia

Ukraine

Lithuania

Spain

UK

Poland

Portugal

Romania

Russia

Austria

Belgium/lLuxembourg

Bulgaria

Czech Republic

Denmark

Finland

France

Germany

Greece

Hungary

Italy

Ireland

Latvia

Lithuania

Netherlands



Characterize contemporary CAD patients (demographic

characteristics, clinical profile)

Objectives

Describe their management and outcomes over 5 years

of follow-up

Identify gaps between treatment and evidence

Determine the long-term prognostic determinants in CAD,

including resting heart rate, and develop a robust risk

prediction model




Stable coronary artery disease proven by history of

at least one of the following:

Inclusion criteria

Chest pain with myocardial ischemia proven by stress ECG,stress echocardiography or myocardial imaging

Coronary angiography showing at least one coronary stenosisof more than 50%

Documented myocardial infarction (more than 3 months ago)

PCI or CABG (more than 3 months ago)



Data

to be

collected

(eCRF)

Follow-up

History and

clinical

examination;

regular

medications

Clinical examination;

regular medications;

clinical outcomes

* Every 6 months – pho ne cal l (health status , addr ess)

Data collection

60 months48 months36 months24 months12 monthsBaseline



Importance of CLARIFY

Will provide data on HR and outcomes in “real world”contemporary outpatients with stable CAD; clinical anddemographic aspects of the disease and treatment

Will provide dynamic estimation of the changing patterns of HR

management, disease presentation, and therapy

Will help to develop a risk prediction tool based on HR

Will give robust data for global and national publications, for

scientific communications (congresses, abstracts), for healthcare administrators

Will provide data for educational programs

HR: heart rate CAD: coronary artery disease

Documents

Clarify Slide Set