Plain English Summary
Not provided at time of registration and not expected to be available in the future
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
ProspeCtive observational LongitudinAl RegIstry oF patients with stable coronary arterY disease
Acronym
CLARIFY
Study hypothesis
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.
Study design
Multicentre prospective observational longitudinal study
Primary study design
Observational
Secondary study design
Longitudinal study
Study setting(s)
Hospital
Study type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Overall study end date
30/07/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
33,000
Total final enrolment
32954
Participant 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
Recruitment start date
01/11/2009
Recruitment end date
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
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
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 |