Condition category
Circulatory System
Date applied
14/10/2009
Date assigned
15/10/2009
Last edited
06/01/2016
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

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

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

2003 results in: http://www.ncbi.nlm.nih.gov/pubmed/13678872
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25577762

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes