PACT (Platelet Activity After Clopidogrel Termination)

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Bristol-Myers Squibb
Information provided by (Responsible Party):
Alan Michelson, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00619073
First received: February 6, 2008
Last updated: November 8, 2012
Last verified: November 2012
Results First Received: January 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Blood Platelets
Clopidogrel
Interventions: Drug: clopidogrel + aspirin
Drug: placebo
Drug: Aspirin

  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
Participants recruited at UMass Medical School in Worcester, MA between April 2008 and May 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
15 healthy participants recruited; 16 screened, 1 excluded (1 did not meet inclusion criteria).

Reporting Groups
  Description
Clopidogrel Then Placebo The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 45 days. After a 30 day washout from completion of first intervention, the subjects will be crossed over to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e. placebo) will then be discontinued and aspirin continued for another 45 days.
Placebo Then Clopidogrel The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 45 days. After a 30 day washout from completion of first intervention, the subjects will be crossed over to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e. clopidogrel) will then be discontinued and aspirin continued for another 45 days.

Participant Flow for 3 periods

Period 1:   First Intervention - 60 Days
    Clopidogrel Then Placebo     Placebo Then Clopidogrel  
STARTED     8     8  
COMPLETED     8     8  
NOT COMPLETED     0     0  

Period 2:   Washout Period (30 Days)
    Clopidogrel Then Placebo     Placebo Then Clopidogrel  
STARTED     8     8  
COMPLETED     8     8  
NOT COMPLETED     0     0  

Period 3:   Second Intervention - 60 Days
    Clopidogrel Then Placebo     Placebo Then Clopidogrel  
STARTED     8     8  
COMPLETED     8     8  
NOT COMPLETED     0     0  



  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
Entire Study Population Includes groups randomized to receive clopidogrel + aspirin first and placebo + aspirin first

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  15  
Age  
[units: participants]
 
Between 18 and 65 years     15  
Gender  
[units: participants]
 
Female     12  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     15  



  Outcome Measures

1.  Primary:   Change From Baseline in Platelet Surface Activated GPIIb-IIIa Complex at 45 Days After Intervention.   [ Time Frame: Baseline and 45 days after intervention ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Alan D. Michelson, M.D.
Organization: Children's Hospital Boston
phone: 617-919-2116
e-mail: alan.michelson@childrens.harvard.edu


Publications of Results:

Responsible Party: Alan Michelson, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00619073     History of Changes
Other Study ID Numbers: CPFS 2008-1
Study First Received: February 6, 2008
Results First Received: January 10, 2012
Last Updated: November 8, 2012
Health Authority: United States: Institutional Review Board