Phase 3
N=7,554
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)
Atrial Fibrillation · Vascular Risk
Bottom Line
View on ClinicalTrials.gov: NCT00249873 ↗Enrolled (actual)
7,554
Serious AEs
29.4%
Results posted
Mar 2010
Primary outcome: Primary: 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 — 832; 924; 84; 105 participants — p=0.0133
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- clopidogrel (SR25990C) (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
832; 924; 84; 105; 285; 391 | 0.0133 sig |
| SECONDARY Occurrence of Stroke |
296; 408 | <0.001 sig |
| SECONDARY Death From Any Cause (Cardiovascular and Noncardiovascular) |
825; 841 | 0.696 |
| SECONDARY Adjudicated Major Bleedings |
251; 162 | <0.001 sig |
Summary
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.
Eligibility 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, 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;
Data sourced from ClinicalTrials.gov (NCT00249873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.