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 designMulticentre prospective observational longitudinal study
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleProspeCtive observational LongitudinAl RegIstry oF patients with stable coronary arterY disease
Study acronymCLARIFY
Study objectivesMost 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) studiedCoronary artery disease
InterventionThe 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 typeOther
Primary outcome measureInformation 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 measuresNo secondary outcome measures
Overall study start date01/11/2009
Completion date30/07/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants33,000
Total final enrolment32954
Key inclusion criteriaOutpatients 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 criteria1. 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 enrolment01/11/2009
Date of final enrolment30/07/2015

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.