Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Sanofi
ClinicalTrials.gov Identifier:
NCT00249873
First received: November 4, 2005
Last updated: March 31, 2010
Last verified: March 2010
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
  Hide Participant Flow

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  
Significant neutropenia                 0                 0  
Severa 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  
Thrombo-embolitic/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
  Hide Baseline Characteristics

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  
Number of Participants  
[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]
     
0     105     101     206  
1     1360     1338     2698  
2     1263     1315     2578  
>2     1040     1028     2068  
Missing     4     0     4  
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  
[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.



  Outcome Measures
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided by Sanofi

Publications automatically indexed to this study:

Responsible Party: International Clinical Development Study Director, Sanofi-aventis
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: March 31, 2010
Health Authority: United States: Food and Drug Administration