Condition category
Circulatory System
Date applied
13/05/2011
Date assigned
13/06/2011
Last edited
12/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

http://www.clarify-registry.com

Contact information

Type

Scientific

Primary contact

Prof Philippe Gabriel Steg

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2009

Overall trial end date

30/07/2015

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

Target number of participants

33,000

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

Trial 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

http://www.servier.com/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25051258
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25110899
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25915904
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25147344
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26813548

Publication citations

  1. Results

    Kalra PR, García-Moll X, Zamorano J, Kalra PA, Fox KM, Ford I, Ferrari R, Tardif JC, Tendera M, Greenlaw N, Steg PG, , Impact of chronic kidney disease on use of evidence-based therapy in stable coronary artery disease: a prospective analysis of 22,272 patients., PLoS ONE, 2014, 9, 7, e102335, doi: 10.1371/journal.pone.0102335.

  2. Results

    Steg PG, Greenlaw N, Tendera M, Tardif JC, Ferrari R, Al-Zaibag M, Dorian P, Hu D, Shalnova S, Sokn FJ, Ford I, Fox KM, , Prevalence of Anginal Symptoms and Myocardial Ischemia and Their Effect on Clinical Outcomes in Outpatients With Stable Coronary Artery Disease: Data From the International Observational CLARIFY Registry., JAMA Intern Med, 2014, doi: 10.1001/jamainternmed.2014.3773.

  3. Results

    Fauchier L, Greenlaw N, Ferrari R, Ford I, Fox KM, Tardif JC, Tendera M, Steg PG; CLARIFY Investigators, Use of Anticoagulants and Antiplatelet Agents in Stable Outpatients with Coronary Artery Disease and Atrial Fibrillation. International CLARIFY Registry, PLoS One, 2015 , 10, 4, e0125164, doi: 10.1371/journal.pone.0125164.

  4. Results

    Sun YH, Yu JM, Hu DY; Investigator of CLARIFY, Status of β-blocker use and heart rate control in Chinese patients with stable coronary artery disease, Zhonghua Xin Xue Guan Bing Za Zhi, 2016 , 44, 1, 19-26, doi: 10.3760/cma.j.issn.0253-3758.2016.01.006.

  5. Results

    Ferrari R, Ford I, Greenlaw N, Tardif JC, Tendera M, Abergel H, Fox K, Hu D, Shalnova S, Steg PG; CLARIFY Registry Investigators, Geographical variations in the prevalence and management of cardiovascular risk factors in outpatients with CAD: Data from the contemporary CLARIFY registry, Eur J Prev Cardiol, 2015 , 22, 8, 1056-1065, doi: 10.1177/2047487314547652.

Additional files

Editorial Notes

12/04/2016: Publication reference added. 28/01/2016: Publication reference added.