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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00249873
First received: November 4, 2005
Last updated: May 20, 2015
Last verified: May 2015
Results First Received: March 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Atrial Fibrillation
Vascular Risk
Interventions: Drug: clopidogrel (SR25990C)
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled from June 2003 until May 2006. The study was conducted at 580 centers in 33 countries. The planned final follow-up visit date ensuring a median follow-up of three years was November 2008. The follow-up of the study was actually completed on March 2009 corresponding to an actual median follow-up of 3.5 years.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Clopidogrel + ASA Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
Placebo + ASA Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)

Participant Flow:   Overall Study
    Clopidogrel + ASA   Placebo + ASA
STARTED   3772 [1]   3782 [1] 
COMPLETED   2442 [2]   2528 [2] 
NOT COMPLETED   1330   1254 
Not treated                7                8 
Significant thrombocytopenia                9                8 
Severe allergic reaction                8                1 
Serious haemorrhagic Adverse Event                74                30 
Other Serious Adverse Event                86                97 
Qualifying condition not present                20                23 
Contraindication to oral anticoagulant                4                8 
Withdrawal by Subject                504                466 
Lost to Follow-up                4                7 
Minor bleeding                99                37 
Non-compliance                41                46 
Other non serious Adverse Event                112                108 
Other contraindicated medication                1                0 
Patient not wish to continue after May08                3                4 
Physician withdrew consent                59                60 
Open label clopidogrel required                31                42 
Angiotensin II receptor blocker required                1                0 
Oral anticoagulant required                159                157 
Study drug intolerance                5                0 
Surgery/ procedure                9                9 
Event related to cardiac condition                12                21 
Thromboembolic/outcome event                82                122 
[1] randomized patients: patients remained in the study whether treated or not until planned study end
[2] started and completed study drug



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Clopidogrel + ASA Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
Placebo + ASA Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
Total Total of all reporting groups

Baseline Measures
   Clopidogrel + ASA   Placebo + ASA   Total 
Overall Participants Analyzed 
[Units: Participants]
 3772   3782   7554 
Age, Customized 
[Units: Participants]
     
18 to <65 years   931   935   1866 
65 to <75 years   1291   1258   2549 
>= 75 years   1550   1589   3139 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.9  (10.2)   71.1  (10.2)   71.0  (10.2) 
Gender 
[Units: Participants]
     
Female   1560   1597   3157 
Male   2212   2185   4397 
CHADS2 Score [1] 
[Units: Participants]
     
 105   101   206 
 1360   1338   2698 
 1263   1315   2578 
>2   1040   1028   2068 
Missing   4   0   4 
[1] CHADS2 score is the Congestive heart failure, High blood pressure, Age, Diabetes, Stroke 2 score. It is a validated clinical prediction rule for determining the risk of stroke. It assigns points (0-6) depending on the presence or absence of co-morbidities such as history of Congestive heart failure, hypertension, Age, history of Diabetes, previous Stroke. A high score means higher risk of stroke.
Sitting Systolic Blood Pressure 
[Units: Participants]
     
<120 mmHg   603   620   1223 
>=120 mmHg   3166   3159   6325 
Missing   3   3   6 
Body Mass Index (BMI) 
[Units: Kg/m²]
Mean (Standard Deviation)
 28.370  (5.575)   28.459  (6.022)   28.415  (5.803) 


  Outcome Measures
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1.  Primary:   First Occurence of Any Component of the Composite of Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism, Myocardial Infarction or Vascular Death as Per Adjudication   [ Time Frame: expected median follow-up of approximately 3 years ]

2.  Secondary:   Occurrence of Stroke   [ Time Frame: expected median follow-up of approximately 3 years ]

3.  Secondary:   Death From Any Cause (Cardiovascular and Noncardiovascular)   [ Time Frame: expected median follow-up of approximately 3 years ]

4.  Secondary:   Adjudicated Major Bleedings   [ Time Frame: expected median follow-up of approximately 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: International Clinical Development, Clinical Study Director
Organization: sanofi-aventis
e-mail: GV-Contact-us@sanofi-aventis.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00249873     History of Changes
Other Study ID Numbers: EFC4912 A
Study First Received: November 4, 2005
Results First Received: March 8, 2010
Last Updated: May 20, 2015
Health Authority: United States: Food and Drug Administration