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 |
| Protocol serial number | CL3-09490-144 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- 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
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Perindopril |
| Primary outcome measure(s) |
Composite endpoint of cardiovascular mortality, non-fatal myocardial infarction and cardiac arrest resuscitation, measured at 3 months, 6 months and every 6 months thereafter |
| Key secondary outcome measure(s) |
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 |
| Completion date | 20/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
- Austria
- Belgium
- Czech Republic
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Netherlands
- Norway
- Poland
- Portugal
- Slovakia
- Spain
- Sweden
- Switzerland
- Türkiye
Study participating centre
SW3 6NP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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? |
|---|---|---|---|---|---|
| Results article | efficacy results | 06/09/2003 | Yes | No | |
| Results article | risk reduction results | 01/03/2015 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
