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”

The purpose of this study is to determine if irbesartan 300mg once daily (od) compared to placebo tablet (an inert substance) will reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death during approximately 3 years of follow-up in patients with atrial fibrillation and with a systolic blood pressure of at least 110 mmHg associated with at least one major risk of vascular events because they are already enrolled into ACTIVE A or ACTIVE W study.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Efficacy Study

Study Primary Completion Date: May 2009

Intervention(s) in this Clinical Trial

• Drug: Irbesartan
  • oral administration of 300mg once daily
• Drug: placebo
  • oral administration once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• First composite outcome of stroke, myocardial infarction or vascular death
  • Time Frame: study period
    Safety Issue?: No
• Second composite outcome of stroke, myocardial infarction, vascular death or hospitalization for heart failure
  • Time Frame: study period
    Safety Issue?: No

Secondary Measures

• Total mortality, stroke, hospitalization for heart failure and other heart failure episodes defined as evidence of symptoms or signs of heart failure (with or without hospitalization)
  • Time Frame: study period
    Safety Issue?: No

Inclusion Criteria:

Should fulfill first the eligibility criteria for Active A or Active W study and :

• a) to do not have a systolic blood pressure above 110 mm Hg;
• b) not already receiving an angiotensin receptor blocking agent, unless they are willing and able to be changed to another antihypertensive agent;
• c) no previous intolerence to angiotensin receptor blocking agents;
• d) no proven indication for angiotensin receptor blocking agents, unless an ACE inhibitor can be substituted.

Exclusion Criteria:

Patients will be excluded from ACTIVE if any of the following are present:

• a) requirement for clopidogrel (such as recent coronry stent procedure)
• b) requirement for oral anticoagulant (such as prosthetic mechanical heart valve);
• c) prior intolerance to ASA or clopidogrel;
• d) documented peptic ulcer disease within the previous 6 months;
• e) prior intracerebral hemorrhage;
• f) significant thrombocytopenia; (platelet count <50 x 10(9)/L)
• g) psyghosocial reason making study participation impractical;
• h) geographic reason making study participation impractical;
• i) ongoing alcohol abuse;
• j) mitral stenosis,
• k) 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;
• l) severe comorbid condition such that the patient is not expected to survive 6 months;
• m) patient currently receiving an investigational pharmacologic agent;
• n) requirement for chronic (> 3 months) non-COX-2 inhibitor NSAID therapy unless willing enrolled in ACTIVE A.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Salim YUSUF, Prof. Study Chair Hamilton Health Sciences Corporation  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00249795

Study ID Number: EFC4912 I

ClinicalTrials.gov Identifier: NCT00249795

Health Authority: United States: Food and Drug Administration