Study 1 of 1 for search of: NCT00249873
Previous Study Return to Search Results Next Study

Full Text View
Tabular View
No Study Results Posted
Related Studies
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)
This study has been completed.
First Received: November 4, 2005   Last Updated: April 6, 2009   History of Changes
Sponsor: Sanofi-Aventis
Collaborator: Bristol-Myers Squibb
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00249873
  Purpose

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.


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

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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-Aventis:

Primary Outcome Measures:
  • Primary outcome of the ACTIVE A trial: time to the first outcome of stroke, non-Central Nervous System 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 of ACTIVE A trial: major hemorrhage, total mortality and stroke [ Time Frame: during approximately three years of follow up ] [ Designated as safety issue: Yes ]

Enrollment: 7554
Study Start Date: June 2003
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: clopidogrel (SR25990C)
75 mg once daily in combination with aspirin
2: Placebo Comparator Drug: placebo
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:

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, 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;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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249873

  Show 30 Study Locations
Sponsors and Collaborators
Sanofi-Aventis
Bristol-Myers Squibb
Investigators
Study Chair: Philippe YUSUF, Prof. Hamilton Health Sciences Corporation
  More Information

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Sanofi-aventis ( ICD Study Director )
Study ID Numbers: EFC4912 A
Study First Received: November 4, 2005
Last Updated: April 6, 2009
ClinicalTrials.gov Identifier: NCT00249873     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Atrial fibrillation
Anticoagulant therapy
Thromboembolic prevention

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

ClinicalTrials.gov processed this record on February 08, 2010