Contact information
Type
Scientific
Primary contact
Prof K Fox
ORCID ID
Contact details
Royal Brompton National Heart & Lung Hospital
Sydney Street
London
SW3 6NP
United Kingdom
+44 (0)20 7351 8626
K.Fox@rbht.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CL3-09490-144
Study information
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
Acronym
EUROPA
Study hypothesis
To evaluate the effect of perindopril on cardiovascular events in patients with stable coronary artery disease and without heart failure.
Ethics approval
Ethics approval was obtained before recruitment of the first participants
Study design
Randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
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
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 names
Perindopril
Primary outcome measures
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 trial start date
22/10/1997
Overall trial end date
20/05/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 years or more, both genders
2. Stable documented coronary artery disease
3. Not scheduled for revascularisation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12230
Participant 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
Recruitment start date
22/10/1997
Recruitment end date
20/05/2003
Locations
Countries of recruitment
Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom
Trial participating centre
Royal Brompton National Heart & Lung Hospital
London
SW3 6NP
United Kingdom
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
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
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 statement:
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.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
http://clinicaltrials.servier.com/wp-content/uploads/CL3-9490-144_synopsis_report.pdf
Publication summary
2003 efficacy results in: http://www.ncbi.nlm.nih.gov/pubmed/13678872
2015 risk reduction results in: http://www.ncbi.nlm.nih.gov/pubmed/25577762
Publication citations
-
Results
Fox KM, , Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease: randomised, double-blind, placebo-controlled, multicentre trial (the EUROPA study)., Lancet, 2003, 362, 9386, 782-788.
-
Results
van der Leeuw J, Oemrawsingh RM, van der Graaf Y, Brugts JJ, Deckers JW, Bertrand M, Fox K, Ferrari R, Remme WJ, Simoons ML, Boersma E, Visseren FL, Prediction of absolute risk reduction of cardiovascular events with perindopril for individual patients with stable coronary artery disease - results from EUROPA, Int J Cardiol, 2015, 182, 194-199, doi: 10.1016/j.ijcard.2014.12.046.