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The management of outpatients with stablecoronary artery disease in clinical practice
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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
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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
CAD: coronary artery disease
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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
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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
CAD: coronary artery disease
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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)
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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
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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