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Trial record 65 of 1254 for:    ASPIRIN AND Platelet Aggregation

PACT (Platelet Activity After Clopidogrel Termination) (PACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00619073
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : November 6, 2012
Last Update Posted : May 31, 2018
Sponsor:
Collaborators:
Sanofi
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Massachusetts, Worcester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Blood Platelets
Clopidogrel
Interventions Drug: clopidogrel + aspirin
Drug: placebo
Drug: Aspirin
Enrollment 15
Recruitment Details Participants recruited at UMass Medical School in Worcester, MA between April 2008 and May 2009.
Pre-assignment Details 15 healthy participants recruited; 16 screened, 1 excluded (1 did not meet inclusion criteria).
Arm/Group Title Clopidogrel Then Placebo Placebo Then Clopidogrel
Hide Arm/Group Description 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. 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.
Period Title: First Intervention - 60 Days
Started 8 8
Completed 8 8
Not Completed 0 0
Period Title: Washout Period (30 Days)
Started 8 8
Completed 8 8
Not Completed 0 0
Period Title: Second Intervention - 60 Days
Started 8 8
Completed 8 8
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to receive clopidogrel + aspirin first and placebo + aspirin first
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Between 18 and 65 years Number Analyzed 15 participants
15
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
12
  80.0%
Male
3
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Change From Baseline in Platelet Surface Activated GPIIb-IIIa Complex at 45 Days After Intervention.
Hide Description Value at 45 days after intervention minus value at baseline in platelet surface activated GPIIb-IIIa complex using flow cytometry.The types and concentrations of agonists used in the flow cytometry assays reported here were: ADP 0.5, 1, and 20 µmol/L; thrombin receptor activating peptide (TRAP) 1 and 20 µmol/L; and a combination of collagen 5 µg/mL and epinephrine 5 µmol/L. Mean Florescence Intensity (MFI) is used as unit of measure. MFI indicates relative degree of shift in fluorescence intensity of a population of platelets in arbitrary units.
Time Frame Baseline and 45 days after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel + Aspirin Placebo + Aspirin
Hide Arm/Group Description:
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 43 days.
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 43 days.
Overall Number of Participants Analyzed 15 15
Mean (Standard Error)
Unit of Measure: mean fluorescence intensity (MFI)
123.2  (17.6) 126.7  (17.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clopidogrel + Aspirin Placebo + Aspirin
Hide Arm/Group Description 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 43 days. 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 43 days.
All-Cause Mortality
Clopidogrel + Aspirin Placebo + Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clopidogrel + Aspirin Placebo + Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clopidogrel + Aspirin Placebo + Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
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
Responsible Party: University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00619073     History of Changes
Other Study ID Numbers: CPFS 2008-1
First Submitted: February 6, 2008
First Posted: February 20, 2008
Results First Submitted: January 10, 2012
Results First Posted: November 6, 2012
Last Update Posted: May 31, 2018