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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00243178




Registration number
NCT00243178
Ethics application status
Date submitted
20/10/2005
Date registered
21/10/2005
Date last updated
19/10/2009

Titles & IDs
Public title
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE W)
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
EFC4912 W
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Vascular Risk 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 - clopidogrel (SR25990C)

Treatment: Drugs: clopidogrel (SR25990C)
75 mg once daily in combination with aspirin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death
Timepoint [1] 0 0
during approximately three years of follow-up
Secondary outcome [1] 0 0
Secondary outcomes: major hemorrhage, total mortality and stroke.
Timepoint [1] 0 0
during approximately three years of follow-up

Eligibility
Key inclusion criteria
* Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or on two ECG recorded at two weeks a part during 6 months prior to study enrollment.
* Evidence of high risk of vascular events: at least one of the following risk criteria must be present:

* are 75 years or greater;
* on treatment for systemic hypertension;
* prior stroke, TIA, or non-CNS systemic embolus;
* left ventricular dysfunction with left ventricular ejection fraction (EF) estimated by echocardiogram or angiogram (radionuclide or contrast) to be < 45%;
* peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation, or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio < 0.9);
* age 55 to 74 years; AND
* either diabetes mellitus requiring drug therapy, or documented previous myocardial infarction, or documented coronary artery disease.
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 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 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; OR
* requirement for chronic (> 3 months) non-COX-2 inhibitor NSAID therapy.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2005
Sample size
Target
Accrual to date
Final
6706
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
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Belgium
State/province [3] 0 0
Diegem
Country [4] 0 0
Brazil
State/province [4] 0 0
Sao Paulo
Country [5] 0 0
Canada
State/province [5] 0 0
Laval
Country [6] 0 0
Chile
State/province [6] 0 0
Santiago
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Praha
Country [8] 0 0
Denmark
State/province [8] 0 0
Horsholm
Country [9] 0 0
Finland
State/province [9] 0 0
Helsinki
Country [10] 0 0
France
State/province [10] 0 0
Paris
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Greece
State/province [12] 0 0
Athens
Country [13] 0 0
Hong Kong
State/province [13] 0 0
Causeway Bay
Country [14] 0 0
Hungary
State/province [14] 0 0
Budapest
Country [15] 0 0
Israel
State/province [15] 0 0
Natanya
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
Russian Federation
State/province [23] 0 0
Moscow
Country [24] 0 0
Singapore
State/province [24] 0 0
Singapore
Country [25] 0 0
South Africa
State/province [25] 0 0
Midrand
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Sweden
State/province [27] 0 0
Bromma
Country [28] 0 0
Switzerland
State/province [28] 0 0
Geneva
Country [29] 0 0
Taiwan
State/province [29] 0 0
Taipei
Country [30] 0 0
Turkey
State/province [30] 0 0
Istanbul
Country [31] 0 0
United Kingdom
State/province [31] 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 is to determine if the combination of Clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a vitamin K antagonist) will result in the same risk of the composite outcome of stroke, non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy.
Trial website
https://clinicaltrials.gov/study/NCT00243178
Trial related presentations / publications
ACTIVE Writing Group of the ACTIVE Investigators; Connolly S, Pogue J, Hart R, Pfeffer M, Hohnloser S, Chrolavicius S, Pfeffer M, Hohnloser S, Yusuf S. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet. 2006 Jun 10;367(9526):1903-12. doi: 10.1016/S0140-6736(06)68845-4.
Flaker GC, Pogue J, Yusuf S, Pfeffer MA, Goldhaber SZ, Granger CB, Anand IS, Hart R, Connolly SJ; Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE) Investigators. Cognitive function and anticoagulation control in patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes. 2010 May;3(3):277-83. doi: 10.1161/CIRCOUTCOMES.109.884171. Epub 2010 Mar 16.
Cairns JA, Wittes J, Wyse DG, Pogue J, Gent M, Hirsh J, Marler J, Pritchett EL. Monitoring the ACTIVE-W trial: some issues in monitoring a noninferiority trial. Am Heart J. 2008 Jan;155(1):33-41. doi: 10.1016/j.ahj.2007.09.011. Epub 2007 Nov 26.
Hohnloser SH, Pajitnev D, Pogue J, Healey JS, Pfeffer MA, Yusuf S, Connolly SJ; ACTIVE W Investigators. Incidence of stroke in paroxysmal versus sustained atrial fibrillation in patients taking oral anticoagulation or combined antiplatelet therapy: an ACTIVE W Substudy. J Am Coll Cardiol. 2007 Nov 27;50(22):2156-61. doi: 10.1016/j.jacc.2007.07.076. Epub 2007 Nov 13.
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/NCT00243178