Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00249873 |
Recruitment Status :
Completed
First Posted : November 7, 2005
Results First Posted : March 26, 2010
Last Update Posted : June 15, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation Vascular Risk | Drug: clopidogrel (SR25990C) Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7554 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
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 Start Date : | June 2003 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | March 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Clopidogrel + ASA
Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
|
Drug: clopidogrel (SR25990C)
oral administration (tablets)
Other Name: Plavix® |
Placebo Comparator: Placebo + ASA
Matching placebo of clopidogrel 75 mg od plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
|
Drug: placebo
oral administration (tablets) |
- First Occurence of Any Component of the Composite of Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism, Myocardial Infarction or Vascular Death as Per Adjudication [ Time Frame: expected median follow-up of approximately 3 years ]
The primary event is the first occurence of any adjudicated component of the following cluster over the duration of follow-up :
- stroke (nonfatal or fatal)
- myocardial infarction (nonfatal or fatal)
- non-CNS systemic embolism
- vascular death
The primary efficacy analysis is performed on the time from randomization to this primary event. Numbers of patients with the composite event over the duration of the follow-up are presented by arm group.
- Occurrence of Stroke [ Time Frame: expected median follow-up of approximately 3 years ]The event is the occurence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) after validation of the Event Adjudication Committee . The analysis is performed on the time from randomization to the occurrence of this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group.
- Death From Any Cause (Cardiovascular and Noncardiovascular) [ Time Frame: expected median follow-up of approximately 3 years ]The considered event is death from any cause. The analysis is performed on the time from randomization to this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group.
- Adjudicated Major Bleedings [ Time Frame: expected median follow-up of approximately 3 years ]The number of participants with at least one major bleeding, validated by the Event Adjudication Committee are counted over the duration of the follow-up (including after permanent discontinuation of the study drug).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 :
- are 75 years greater;
- on treatment for systemic hypertension;
- prior stroke, Transient Ischemic Attack (TIA) or non-Central Nervous System (non-CNS) systemic embolus;
- left ventricular dysfunction with left ventricular ejection fraction (EF) estimated by echocardiogram or angiogram (radionuclide or contrast) to be < 45%;
- peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation, or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio < 0.9);
- 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 :
- requirement for clopidogrel (such as recent coronary stent procedure)
- requirement for oral anticoagulant (such as prosthetic mechanical heart valve);
- prior intolerance to ASA or clopidogrel;
- documented peptic ulcer disease within the previous 6 months;
- prior intracerebral hemorrhage;
- significant thrombocytopenia; (platelet count < 50 x 10(9)/L)
- psychosocial reason making study participation impractical;
- geographic reason making study participation impractical;
- ongoing alcohol abuse;
- mitral stenosis,
- 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; (severe comorbid condition such that the patient is not expected to survive 6 months;
- patient currently receiving an investigational pharmacologic agent;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249873
United States, New Jersey | |
Sanofi-Aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Argentina | |
Sanofi-Aventis Administrative Office | |
Buenos Aires, Argentina | |
Australia | |
Sanofi-Aventis Administrative Office | |
Macquarie Park, Australia | |
Austria | |
Sanofi-Aventis | |
Wien, Austria | |
Belgium | |
Sanofi-aventis Administrative Office | |
Diegem, Belgium | |
Brazil | |
Sanofi-Aventis Administrative Office | |
Sao Paulo, Brazil | |
Canada | |
Sanofi-Aventis Administrative Office | |
Laval, Canada | |
Chile | |
Sanofi-Aventis Administrative Office | |
Santiago, Chile | |
Czech Republic | |
Sanofi-Aventis Administrative Office | |
Praha, Czech Republic | |
Denmark | |
Sanofi-Aventis Administrative Office | |
Horsholm, Denmark | |
Finland | |
Sanofi-Aventis Administrative Office | |
Helsinki, Finland | |
France | |
Sanofi-Aventis Administrative Office | |
Paris, France | |
Germany | |
Sanofi-Aventis Administrative Office | |
Berlin, Germany | |
Greece | |
Sanofi-Aventis Administrative Office | |
Athens, Greece | |
Hong Kong | |
Sanofi-Aventis Administrative Office | |
Causeway Bay, Hong Kong | |
Hungary | |
Sanofi-Aventis Administrative Office | |
Budapest, Hungary | |
Italy | |
Sanofi-Aventis Administrative Office | |
Milano, Italy | |
Malaysia | |
Sanofi-Aventis Administrative Office | |
Kuala Lumpur, Malaysia | |
Mexico | |
Sanofi-Aventis Administrative Office | |
Mexico, Mexico | |
Netherlands | |
Sanofi-Aventis Administrative Office | |
Gouda, Netherlands | |
Norway | |
Sanofi-Aventis Administrative Office | |
Lysaker, Norway | |
Poland | |
Sanofi-Aventis Administrative Office | |
Warszawa, Poland | |
Portugal | |
Sanofi-Aventis Administrative Office | |
Porto Salvo, Portugal | |
Singapore | |
Sanofi-Aventis Administrative Office | |
Singapore, Singapore | |
South Africa | |
Sanofi-Aventis Administrative Office | |
Midrand, South Africa | |
Spain | |
Sanofi-Aventis Administrative Office | |
Barcelona, Spain | |
Sweden | |
Sanofi-Aventis Administrative Office | |
Bromma, Sweden | |
Switzerland | |
Sanofi-Aventis Administrative Office | |
Geneva, Switzerland | |
Taiwan | |
Sanofi-Aventis Administrative Office | |
Taipei, Taiwan | |
United Kingdom | |
Sanofi-Aventis Administrative Office | |
Guildford Surrey, United Kingdom |
Study Chair: | Philippe YUSUF, Prof. | Hamilton Health Sciences Corporation |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00249873 |
Other Study ID Numbers: |
EFC4912 A |
First Posted: | November 7, 2005 Key Record Dates |
Results First Posted: | March 26, 2010 |
Last Update Posted: | June 15, 2015 |
Last Verified: | May 2015 |
Atrial fibrillation Anticoagulant therapy Thromboembolic prevention |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Clopidogrel Platelet Aggregation Inhibitors |
Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |