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Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)
This study has been completed.
First Received: November 4, 2005   Last Updated: October 20, 2009   History of Changes
Sponsor: Sanofi-Aventis
Collaborator: Bristol-Myers Squibb
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00249795
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Cardiovascular Disease
Drug: Irbesartan
Drug: placebo
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial 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:
  • First composite outcome of stroke, myocardial infarction or vascular death [ Time Frame: study period ] [ Designated as safety issue: No ]
  • Second composite outcome of stroke, myocardial infarction, vascular death or hospitalization for heart failure [ Time Frame: study period ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 9000
Study Start Date: June 2003
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Irbesartan
oral administration of 300mg once daily
2: Placebo Comparator Drug: placebo
oral administration once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249795

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

No publications provided

Responsible Party: Sanofi-aventis ( ICD Study Director )
Study ID Numbers: EFC4912 I, SR25990C
Study First Received: November 4, 2005
Last Updated: October 20, 2009
ClinicalTrials.gov Identifier: NCT00249795     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Atrial fibrillation
Cardivascular disease
angiotensin II blocker

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