Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)

Condition(s) targeted: Atrial Fibrillation; Vascular Risk

Intervention: Clopidogrel (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Philippe YUSUF, Prof., Study Chair, Affiliation: Hamilton Health Sciences Corporation

The purpose of this study is to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily recommended dose) for preventing vascular events such as stroke and heart attack during approximately three years of follow-up in patients with atrial fibrillation associated with at least one major risk factor of vascular event such as elderly, blood pressure increase, history of stroke or transient ischemic attack or left ventricular dysfunction etc. The study will also accept patients with atrial fibrillation and unwilling to take oral anticoagulant therapy.

Official title: A Parallel Randomized Controlled Evaluation of Clopidogrel Plus Aspirin, With Factorial Evaluation of Irbesartan, for the Prevention of Vascular Events, in Patients With Atrial Fibrillation

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: The primary outcome of the ACTIVE A trial will be the time to the first outcome of stroke, non-Central Nervous System systemic embolism, myocardial infarction or vascular death during approximately three years of follow up.

Secondary outcome:

The secondary outcomes of ACTIVE A trial will be :

- Major hemorrhage, total mortality and stroke.The other outcomes will include individual components of the primary outcome and all safety criteria including serious adverse events.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

To be eligible for ACTIVE A patients must have in same time the three following conditions :

- Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or two

ECGs recorded at two weeks a part during 6 months prior to study enrollment.

- Evidence of high risk of vascular events : at least one of the following risk criteria

must be present :

- a) are 75 years greater;

- b) on treatment for systemic hypertension;

- c) prior stroke, TIA or non-CNS systemic embolus;

- d) left ventricular dysfunction with left ventricular ejection fraction (EF)

estimated by echocardiogram or angiogram (radionuclide or contrast) to be < 45%;

- e) peripheral vascular disease (previous peripheral artery revascularization,

limb and foot amputation, or the combination of current intermittent claudition and ankle arm systolic blood pressure ratio < 0. 9);

- f) age 55 to 74 years and either;f1) diabetes mellitus requiring drug therapy, or

f2) documented previous myocardial infarction or documented coronary artery disease.

- To have either a contraindication to use an oral anticoagulant treatment or they are

unwilling to take an oral anticoagulant treatment.

Exclusion Criteria:

Patients will be excluded from ACTIVE if any of the following are present :

- a) requirement for clopidogrel (such as recent coronry stent procedure)

- b) requirement for oral anticoagulant (such as prosthetic mechanical heart valve);

- c) prior intolerance to ASA or clopidogrel;

- d) documented peptic ulcer disease within the previous 6 months;

- e) prior intracerebral hemorrhage;

- f) significant thrombocytopenia; (platelet count < 50 x 10(9)/L)

- g) psychosocial reason making study participation impractical;

- h) geographic reason making study participation impractical;

- i) ongoing alcohol abuse;

- j) mitral stenosis,

- k) pregnant or nursing woman or woman of child bearing potential and not on effective

birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study;

- l) severe comorbid condition such that the patient is not expected to survive 6

months;

- m) patient currently receiving an investigational pharmacologic agent;

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina

Sanofi-Aventis Administrative Office, Macquarie Park, Australia

Sanofi-Aventis, Wien, Austria

Sanofi-aventis Administrative Office, Diegem, Belgium

Sanofi-Aventis Administrative Office, Sao Paulo, Brazil

Sanofi-Aventis Administrative Office, Laval, Canada

Sanofi-Aventis Administrative Office, Santiago, Chile

Sanofi-Aventis Administrative Office, Praha, Czech Republic

Sanofi-Aventis Administrative Office, Horsholm, Denmark

Sanofi-Aventis Administrative Office, Helsinki, Finland

Sanofi-Aventis Administrative Office, Paris, France

Sanofi-Aventis Administrative Office, Berlin, Germany

Sanofi-Aventis Administrative Office, Athens, Greece

Sanofi-Aventis Administrative Office, Causeway Bay, Hong Kong

Sanofi-Aventis Administrative Office, Budapest, Hungary

Sanofi-Aventis Administrative Office, Natanya, Israel

Sanofi-Aventis Administrative Office, Milano, Italy

Sanofi-Aventis Administrative Office, Kuala Lumpur, Malaysia

Sanofi-Aventis Administrative Office, Mexico, Mexico

Sanofi-Aventis Administrative Office, Gouda, Netherlands

Sanofi-Aventis Administrative Office, Lysaker, Norway

Sanofi-Aventis Administrative Office, Warszawa, Poland

Sanofi-Aventis Administrative Office, Porto Salvo, Portugal

Sanofi-Aventis Administrative Office, Moscow, Russian Federation

Sanofi-Aventis Administrative Office, Singapore, Singapore

Sanofi-Aventis Administrative Office, Midrand, South Africa

Sanofi-Aventis Administrative Office, Barcelona, Spain

Sanofi-Aventis Administrative Office, Bromma, Sweden

Sanofi-Aventis Administrative Office, Geneva, Switzerland

Sanofi-Aventis Administrative Office, Taipei, Taiwan

Sanofi-aventis Administrative Office, Istanbul, Turkey

Sanofi-Aventis Administrative Office, Guildford Surrey, United Kingdom

Sanofi-Aventis Administrative Office, Bridgewater, New Jersey 08807, United States

Starting date: June 2003
Ending date: May 2008
Last updated: April 18, 2008