The EUROPA study: EUropean trial on Reduction Of cardiac events with Perindopril in stable coronary Artery
| ISRCTN | ISRCTN37166280 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37166280 |
| Secondary identifying numbers | CL3-09490-144 |
- Submission date
- 14/10/2009
- Registration date
- 15/10/2009
- Last edited
- 18/04/2018
- 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
Contact information
Prof K Fox
Scientific
Scientific
Royal Brompton National Heart & Lung Hospital
Sydney Street
London
SW3 6NP
United Kingdom
| Phone | +44 (0)20 7351 8626 |
|---|---|
| K.Fox@rbht.nhs.uk |
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effects of perindopril on mortality/morbidity in patients with stable coronary artery disease without clinical heart failure: a double-blind, multicentre, randomised trial |
| Study acronym | EUROPA |
| Study objectives | To evaluate the effect of perindopril on cardiovascular events in patients with stable coronary artery disease and without heart failure. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Coronary artery disease |
| Intervention | Perindopril 8 mg per day (4 mg for patients aged 70 or older) or placebo for approximately 4 years treatment, follow-up at 3 months, 6 months and every 6 months thereafter. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Perindopril |
| Primary outcome measure | Composite endpoint of cardiovascular mortality, non-fatal myocardial infarction and cardiac arrest resuscitation, measured at 3 months, 6 months and every 6 months thereafter |
| Secondary outcome measures | Composite endpoints of mortality, non-fatal acute myocardial infarction, unstable angina and cardiac arrest resuscitation and individual endpoints, measured at 3 months, 6 months and every 6 months thereafter |
| Overall study start date | 22/10/1997 |
| Completion date | 20/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 12230 |
| Key inclusion criteria | 1. Aged 18 years or more, both genders 2. Stable documented coronary artery disease 3. Not scheduled for revascularisation |
| Key exclusion criteria | 1. Clinical signs of heart failure requiring treatment with an angiotensin converting enzyme (ACE) inhibitor 2. Uncontrolled treated hypertension 3. Clinically significant obstructive valvular disease 4. Hypertrophic cardiomyopathy |
| Date of first enrolment | 22/10/1997 |
| Date of final enrolment | 20/05/2003 |
Locations
Countries of recruitment
- Austria
- Belgium
- Czech Republic
- Denmark
- England
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Netherlands
- Norway
- Poland
- Portugal
- Slovakia
- Spain
- Sweden
- Switzerland
- Türkiye
- United Kingdom
Study participating centre
Royal Brompton National Heart & Lung Hospital
London
SW3 6NP
United Kingdom
SW3 6NP
United Kingdom
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
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 | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current version as of 28/03/2018: Summary results are published in https://clinicaltrials.servier.com. For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature. IPD sharing plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014. Previous version as of 24/01/2018: Publication plan: All phases - Interventional studies ending before 01/10/2018: Summary results will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study. All phases - Interventional studies ending after 01/10/2018: Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study. Phase 3 only - The results will be published in scientific literature within 18 months after the end of the study. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ if a Marketing Authorisation has been granted after 2014. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | efficacy results | 06/09/2003 | Yes | No | |
| Results article | risk reduction results | 01/03/2015 | Yes | No |
Editorial Notes
18/04/2018: Internal review
28/03/2018: The publication and dissemination plan has been changed.
24/01/2018: Publication plan and IPD sharing statement added.
06/12/2017: results summary added.
