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

Primary Purpose

Atrial Fibrillation, Cardiovascular Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Irbesartan
placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Cardiovascular disease, angiotensin II blocker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

Irbesartan

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication
The first co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal) or vascular death - after validation by the Event Adjudication Committee (EAC).
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication
The second co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal), vascular death or hospitalization for heart failure - after validation by the EAC.

Secondary Outcome Measures

First Occurrence of Stroke
The considered event is the first occurrence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) over the duration of follow-up, after validation by the EAC.
Death From Any Cause
The considered event is the death over the duration of the follow-up whatever the cause, cardiovascular or non-cardiovascular.
First Occurrence of Any Heart Failure (HF) Episode
The considered event is the first occurence of any HF episode defined as evidence of signs and symptoms of HF with or without hospitalization over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).
First Hospitalisation for Heart Failure (HF)
The considered event is the first overnight hospital stay for HF over the duration of the follow-up, after validation by the EAC.
First Hospitalisation for Other Cardiovascular (CV) Cause
The considered event is the overnight hospital stay for any CV cause other than Heart Failure over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).

Full Information

First Posted
November 4, 2005
Last Updated
September 29, 2010
Sponsor
Sanofi
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00249795
Brief Title
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)
Acronym
ACTIVE I
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.
Detailed Description
ACTIVE I was one of the 3 separate but related trials of the ACTIVE program conducted in AF patients at risk of vascular events. Patients were enrolled first into one of the 2 parallel trials of the ACTIVE program evaluating Clopidogrel: ACTIVE A comparing clopidogrel + acetylsalicylic acid (ASA) and ASA alone ACTIVE W comparing clopidogrel + ASA and oral anticoagulant (OAC). Then those satisfying additional criteria related to blood pressure and angiotensin receptor blocking agents were re-randomized in the two ACTIVE I arms according to a separate randomization list.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Cardiovascular Disease
Keywords
Atrial fibrillation, Cardiovascular disease, angiotensin II blocker

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9016 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irbesartan
Arm Type
Experimental
Arm Description
150 mg for 2 weeks, then up-titrated to 300 mg up to final follow-up visit
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo up to final follow-up visit
Intervention Type
Drug
Intervention Name(s)
Irbesartan
Other Intervention Name(s)
Aprovel®
Intervention Description
oral administration (tablets) once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral administration (tablets) once daily
Primary Outcome Measure Information:
Title
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication
Description
The first co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal) or vascular death - after validation by the Event Adjudication Committee (EAC).
Time Frame
Median follow-up of 4.5 years
Title
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication
Description
The second co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal), vascular death or hospitalization for heart failure - after validation by the EAC.
Time Frame
Median follow-up of 4.5 years
Secondary Outcome Measure Information:
Title
First Occurrence of Stroke
Description
The considered event is the first occurrence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) over the duration of follow-up, after validation by the EAC.
Time Frame
Median follow-up of 4.5 years
Title
Death From Any Cause
Description
The considered event is the death over the duration of the follow-up whatever the cause, cardiovascular or non-cardiovascular.
Time Frame
Median follow-up of 4.5 years
Title
First Occurrence of Any Heart Failure (HF) Episode
Description
The considered event is the first occurence of any HF episode defined as evidence of signs and symptoms of HF with or without hospitalization over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).
Time Frame
Median follow-up of 4.5 years
Title
First Hospitalisation for Heart Failure (HF)
Description
The considered event is the first overnight hospital stay for HF over the duration of the follow-up, after validation by the EAC.
Time Frame
Median follow-up of 4.5 years
Title
First Hospitalisation for Other Cardiovascular (CV) Cause
Description
The considered event is the overnight hospital stay for any CV cause other than Heart Failure over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).
Time Frame
Median follow-up of 4.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salim YUSUF, Prof.
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Buenos Aires
Country
Argentina
Facility Name
Sanofi-Aventis Administrative Office
City
Macquarie Park
Country
Australia
Facility Name
Sanofi-Aventis Administrative Office
City
Wien
Country
Austria
Facility Name
Sanofi-Aventis Administrative Office
City
Diegem
Country
Belgium
Facility Name
Sanofi-Aventis Administrative Office
City
Sao Paulo
Country
Brazil
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Santiago
Country
Chile
Facility Name
Sanofi-Aventis Administrative Office
City
Praha
Country
Czech Republic
Facility Name
Sanofi-Aventis Administrative Office
City
Horsholm
Country
Denmark
Facility Name
Sanofi-Aventis Administrative Office
City
Helsinki
Country
Finland
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Athens
Country
Greece
Facility Name
Sanofi-Aventis Administrative Office
City
Causeway Bay
Country
Hong Kong
Facility Name
Sanofi-Aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis Administrative Office
City
Milano
Country
Italy
Facility Name
Sanofi-Aventis Administrative Office
City
Kuala Lumpur
Country
Malaysia
Facility Name
Sanofi-Aventis Administrative Office
City
Mexico
Country
Mexico
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Lysaker
Country
Norway
Facility Name
Sanofi-Aventis Administrative Office
City
Warszawa
Country
Poland
Facility Name
Sanofi-Aventis Administrative Office
City
Porto Salvo
Country
Portugal
Facility Name
Sanofi-Aventis Administrative Office
City
Singapore
Country
Singapore
Facility Name
Sanofi-Aventis Administrative Office
City
Midrand
Country
South Africa
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Bromma
Country
Sweden
Facility Name
Sanofi-Aventis Administrative Office
City
Geneva
Country
Switzerland
Facility Name
Sanofi-Aventis Administrative Office
City
Taipei
Country
Taiwan
Facility Name
Sanofi-Aventis Administrative Office
City
Guildford Surrey
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21388310
Citation
ACTIVE I Investigators; Yusuf S, Healey JS, Pogue J, Chrolavicius S, Flather M, Hart RG, Hohnloser SH, Joyner CD, Pfeffer MA, Connolly SJ. Irbesartan in patients with atrial fibrillation. N Engl J Med. 2011 Mar 10;364(10):928-38. doi: 10.1056/NEJMoa1008816.
Results Reference
derived

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

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