Registry to provide contemporary information regarding characteristics, management and outcomes of outpatients with stable coronary artery disease

ISRCTN	ISRCTN43070564
DOI	https://doi.org/10.1186/ISRCTN43070564
Secondary identifying numbers	N/A

Submission date: 13/05/2011
Registration date: 13/06/2011
Last edited: 09/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration and not expected to be available in the future

Study website

Contact information

Prof Philippe Gabriel Steg
Scientific

Centre Hospitalier Bichat-Claude Bernard
46 Rue Henri Huchard
Paris
75018
France

Study information

Study design	Multicentre prospective observational longitudinal study
Primary study design	Observational
Secondary study design	Longitudinal study
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	ProspeCtive observational LongitudinAl RegIstry oF patients with stable coronary arterY disease
Study acronym	CLARIFY
Study objectives	Most of the data pertaining to patients with stable coronary artery disease come from randomised clinical trials involving highly selective patient population. This large international observational registry will attempt to provide contemporary information regarding characteristics, management and outcomes of outpatients with stable coronary artery disease.
Ethics approval(s)	National Research Ethics Service, Isle of Wight, Portsmouth and Southeast Hampshire Research Ethics Committee, UK approved on 20/11/2009. All other centres obtained ethics approval before recruitment of the first participant.
Health condition(s) or problem(s) studied	Coronary artery disease
Intervention	The registry attempted to collect representative data for each of the participating countries. Representativeness is ensured by a two-tiered process: 1. Determination of physician type in charge of outpatients with stable CAD in a given country and targeting of an appropriate proportion of each of this physician's specialties 2. For each physician, enrollment of consecutive, eligible patients. The data will be collected prospectively using an electronic standardised international case report form (translated into the local language) at baseline and annually during 5 years follow up (at 12+/-3, 24+/-3, 36+/-3, 48+/-3, and 60+/-3 months).
Intervention type	Other
Primary outcome measure	Information collected at baseline will include demographics, medical history, risk factors, employment status, physical examination, heart rate, laboratory values (if available), and current chronic medical treatments. Each annual follow-up visit will collect information regarding clinical events, hospitalisations, interventions, death, employment status, physical examination, heart rate, laboratory values (if available) and current medical therapy (cardiovascular and non-cardiovascular).
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/11/2009
Completion date	30/07/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	33,000
Total final enrolment	32954
Key inclusion criteria	Outpatients with stable coronary artery disease, proven by history of at least one of the following criteria: 1. Documented myocardial infarction (more than 3 months ago) 2. Coronary stenosis of more than 50% proven by coronary angiography 3. Chest pain with proven myocardial ischemia 4. Coronary artery bypass grafting surgery or percutaneous coronary intervention (more than 3 months ago)
Key exclusion criteria	1. Patients hospitalised for cardiovascular disease within last 3 months 2. Patients with planned revascularisation 3. Conditions hampering the participation or the 5-year follow-up
Date of first enrolment	01/11/2009
Date of final enrolment	30/07/2015

Locations

Countries of recruitment

Argentina
Australia
Austria
Bahrain
Barbados
Belgium
Brazil
Bulgaria
Canada
China
Czech Republic
Denmark
France
Germany
Greece
Hungary
Ireland
Italy
Korea, South
Kuwait
Latvia
Lithuania
Malaysia
Mexico
Netherlands
Oman
Poland
Portugal
Qatar
Romania
Russian Federation
Saudi Arabia
Singapore
Slovakia
Slovenia
South Africa
Spain
Switzerland
Thailand
Ukraine
United Arab Emirates
United Kingdom
Viet Nam

Study participating centre

Centre Hospitalier Bichat-Claude Bernard

Paris
75018
France

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/07/2014		Yes	No
Results article	results	01/10/2014		Yes	No
Results article	results	27/04/2015		Yes	No
Results article	results	01/08/2015		Yes	No
Results article	results	01/01/2016		Yes	No
Results article	results	01/07/2019	03/06/2020	Yes	No
Results article	5-year results	15/07/2021	16/07/2021	Yes	No
Results article		07/01/2023	09/01/2023	Yes	No

Editorial Notes

09/01/2023: Publication reference added.
16/07/2021: Publication reference added.
02/06/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2015 reference.
12/04/2016: Publication reference added.
28/01/2016: Publication reference added.