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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00249795




Registration number
NCT00249795
Ethics application status
Date submitted
4/11/2005
Date registered
7/11/2005
Date last updated
15/10/2010

Titles & IDs
Public title
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)
Scientific 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
Secondary ID [1] 0 0
Clopidogrel (SR25990)
Secondary ID [2] 0 0
EFC4912 I
Universal Trial Number (UTN)
Trial acronym
ACTIVE I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Cardiovascular Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Irbesartan
Treatment: Drugs - placebo

Experimental: Irbesartan - 150 mg for 2 weeks, then up-titrated to 300 mg up to final follow-up visit

Placebo comparator: Placebo - Matching placebo up to final follow-up visit


Treatment: Drugs: Irbesartan
oral administration (tablets) once daily

Treatment: Drugs: placebo
oral administration (tablets) once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication
Timepoint [1] 0 0
Median follow-up of 4.5 years
Primary outcome [2] 0 0
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication
Timepoint [2] 0 0
Median follow-up of 4.5 years
Secondary outcome [1] 0 0
First Occurrence of Stroke
Timepoint [1] 0 0
Median follow-up of 4.5 years
Secondary outcome [2] 0 0
Death From Any Cause
Timepoint [2] 0 0
Median follow-up of 4.5 years
Secondary outcome [3] 0 0
First Occurrence of Any Heart Failure (HF) Episode
Timepoint [3] 0 0
Median follow-up of 4.5 years
Secondary outcome [4] 0 0
First Hospitalisation for Heart Failure (HF)
Timepoint [4] 0 0
Median follow-up of 4.5 years
Secondary outcome [5] 0 0
First Hospitalisation for Other Cardiovascular (CV) Cause
Timepoint [5] 0 0
Median follow-up of 4.5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2009
Sample size
Target
Accrual to date
Final
9016
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Belgium
State/province [4] 0 0
Diegem
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Canada
State/province [6] 0 0
Laval
Country [7] 0 0
Chile
State/province [7] 0 0
Santiago
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Praha
Country [9] 0 0
Denmark
State/province [9] 0 0
Horsholm
Country [10] 0 0
Finland
State/province [10] 0 0
Helsinki
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Greece
State/province [13] 0 0
Athens
Country [14] 0 0
Hong Kong
State/province [14] 0 0
Causeway Bay
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Italy
State/province [16] 0 0
Milano
Country [17] 0 0
Malaysia
State/province [17] 0 0
Kuala Lumpur
Country [18] 0 0
Mexico
State/province [18] 0 0
Mexico
Country [19] 0 0
Netherlands
State/province [19] 0 0
Gouda
Country [20] 0 0
Norway
State/province [20] 0 0
Lysaker
Country [21] 0 0
Poland
State/province [21] 0 0
Warszawa
Country [22] 0 0
Portugal
State/province [22] 0 0
Porto Salvo
Country [23] 0 0
Singapore
State/province [23] 0 0
Singapore
Country [24] 0 0
South Africa
State/province [24] 0 0
Midrand
Country [25] 0 0
Spain
State/province [25] 0 0
Barcelona
Country [26] 0 0
Sweden
State/province [26] 0 0
Bromma
Country [27] 0 0
Switzerland
State/province [27] 0 0
Geneva
Country [28] 0 0
Taiwan
State/province [28] 0 0
Taipei
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Guildford Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00249795
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Salim YUSUF, Prof.
Address 0 0
Hamilton Health Sciences Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00249795