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A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients (DECADES)

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00493779
First received: June 27, 2007
Last updated: August 3, 2010
Last verified: June 2010
Results First Received: June 5, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Antiplatelet Aggregation
Intervention: Procedure: Blood Collection

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
103 subjects who were enrolled and treated with clopidogrel, were enrolled, of which 98 subjects had discontinued clopidogrel treatment and entered follow-up phase (study phase).

Reporting Groups
  Description
Clopidogrel Withdrawal Population All enrolled participants in whom clopidogrel treatment was discontinued.

Participant Flow:   Overall Study
    Clopidogrel Withdrawal Population  
STARTED     98 [1]
COMPLETED     97 [2]
NOT COMPLETED     1  
Logistical issue at site                 1  
[1] Number of subjects who had discontinued clopidogrel treatment and entered follow-up phase
[2] Completed follow-up phase



  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 Withdrawal Population All enrolled participants in whom clopidogrel treatment was discontinued.

Baseline Measures
    Clopidogrel Withdrawal Population  
Number of Participants  
[units: participants]
  98  
Age  
[units: years]
Mean ± Standard Deviation
  63.3  ± 8.5  
Age  
[units: years]
Median ( Full Range )
  63  
  ( 44 to 81 )  
Gender  
[units: participants]
 
Female     20  
Male     78  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian     93  
Asian Oriental     5  
Mean Baseline High Sensitivity C-Reactive Protein (hs-CRP)  
[units: mg/L]
Mean ± Standard Deviation
  1.70  ± 2.052  
Mean Baseline Plasma Soluble P-Selectin  
[units: ng/mL]
Mean ± Standard Deviation
  44.59  ± 14.898  
Mean Baseline Soluble CD40 Ligand  
[units: ng/L]
Mean ± Standard Deviation
  223.76  ± 186.513  



  Outcome Measures
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1.  Primary:   Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L)   [ Time Frame: Week 1, Week 2, Week 3, Week 4 (primary timepoint) ]

2.  Secondary:   Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin   [ Time Frame: Week 1, Week 2, Week 3, Week 4 ]

3.  Secondary:   Adjusted Mean Percent Changes From Baseline in Hs-CRP   [ Time Frame: Week 1, Week 2, Week 3, Week 4 ]

4.  Secondary:   Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up   [ Time Frame: Throughout 4-week follow-up period ]


  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
The open-label and exploratory nature of this small study and the absence of control group inherently limit the interpretability of the results.


  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: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications:

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00493779     History of Changes
Other Study ID Numbers: CV149-208, Eudract number: 2007-000713-11
Study First Received: June 27, 2007
Results First Received: June 5, 2009
Last Updated: August 3, 2010
Health Authority: France: Agence du Medicament (Drug Agency)