Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I) (ACTIVE I)
Atrial Fibrillation, Cardiovascular Disease
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Cardiovascular disease, angiotensin II blocker
Eligibility Criteria
Inclusion Criteria: Should fulfill the eligibility criteria for ACTIVE A or ACTIVE W trial and: have a systolic blood pressure of at least 110 mmHg not already receiving an angiotensin receptor blocking agent, unless they are willing and able to be changed to another antihypertensive agent no previous intolerance to angiotensin receptor blocking agents no proven indication for angiotensin receptor blocking agents, unless an Angiotensin Converting Enzyme (ACE) inhibitor can be substituted Exclusion Criteria: Patients will be excluded from ACTIVE study 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 acetylsalicyclic acid (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 requirement for chronic (> 3 months) non-cyclooxygenase-2 (non-COX-2) inhibitor nonsteroidal anti-inflammatory drug (NSAID) therapy unless willing enrolled in ACTIVE A
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Irbesartan
Placebo
150 mg for 2 weeks, then up-titrated to 300 mg up to final follow-up visit
Matching placebo up to final follow-up visit