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

This study has been terminated.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00243178
First received: October 20, 2005
Last updated: October 16, 2009
Last verified: October 2009
  Purpose

The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a vitamin K antagonist) will result in the same risk of the composite outcome of stroke, non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy.


Condition Intervention Phase
Atrial Fibrillation
Vascular Risk
Drug: clopidogrel (SR25990C)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death [ Time Frame: during approximately three years of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes: major hemorrhage, total mortality and stroke. [ Time Frame: during approximately three years of follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 6706
Study Start Date: July 2003
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: clopidogrel (SR25990C)
    75 mg once daily in combination with aspirin
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or on two ECG 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 or greater;
    • on treatment for systemic hypertension;
    • prior stroke, TIA, or 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 diabetes mellitus requiring drug therapy, or documented previous myocardial infarction, or documented coronary artery disease.

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; OR
    • requirement for chronic (> 3 months) non-COX-2 inhibitor NSAID therapy.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243178

  Show 32 Study Locations
Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Study Chair: Salim YUSUF, Prof. Hamilton Health Sciences Corporation
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00243178     History of Changes
Other Study ID Numbers: EFC4912 W
Study First Received: October 20, 2005
Last Updated: October 16, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Atrial fibrillation
Anticoagulant therapy
Thromboembolic prevention

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Clopidogrel
Irbesartan
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 29, 2014