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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00249873
First received: November 4, 2005
Last updated: March 31, 2010
Last verified: March 2010

November 4, 2005
March 31, 2010
June 2003
March 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]

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.

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.
Complete list of historical versions of study NCT00249873 on ClinicalTrials.gov Archive Site
  • Occurrence of Stroke [ Time Frame: expected median follow-up of approximately 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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).
  • 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.
Not Provided
Not Provided
 
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Atrial Fibrillation
  • Vascular Risk
  • Drug: clopidogrel (SR25990C)
    oral administration (tablets)
    Other Name: Plavix®
  • Drug: placebo
    oral administration (tablets)
  • Experimental: Clopidogrel + ASA
    Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
    Intervention: Drug: clopidogrel (SR25990C)
  • 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)
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7554
March 2009
March 2009   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Italy,   Malaysia,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom
 
NCT00249873
EFC4912 A
Yes
International Clinical Development Study Director, Sanofi-aventis
Sanofi
Bristol-Myers Squibb
Study Chair: Philippe YUSUF, Prof. Hamilton Health Sciences Corporation
Sanofi
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP