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Trial Outcomes & Findings for PACT (Platelet Activity After Clopidogrel Termination) (NCT NCT00619073)

NCT ID: NCT00619073

Last Updated: 2018-05-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Baseline and 45 days after intervention

Results posted on

2018-05-31

Participant Flow

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

15 healthy participants recruited; 16 screened, 1 excluded (1 did not meet inclusion criteria).

Participant milestones

Participant milestones
Measure
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.
First Intervention - 60 Days
STARTED
8
8
First Intervention - 60 Days
COMPLETED
8
8
First Intervention - 60 Days
NOT COMPLETED
0
0
Washout Period (30 Days)
STARTED
8
8
Washout Period (30 Days)
COMPLETED
8
8
Washout Period (30 Days)
NOT COMPLETED
0
0
Second Intervention - 60 Days
STARTED
8
8
Second Intervention - 60 Days
COMPLETED
8
8
Second Intervention - 60 Days
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PACT (Platelet Activity After Clopidogrel Termination)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Entire Study Population
n=15 Participants
Includes groups randomized to receive clopidogrel + aspirin first and placebo + aspirin first
Age, Customized
Between 18 and 65 years
15 participants
n=93 Participants
Sex: Female, Male
Female
12 Participants
n=93 Participants
Sex: Female, Male
Male
3 Participants
n=93 Participants
Region of Enrollment
United States
15 participants
n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 45 days after intervention

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.

Outcome measures

Outcome measures
Measure
Clopidogrel + Aspirin
n=15 Participants
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.
Placebo + Aspirin
n=15 Participants
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.
Change From Baseline in Platelet Surface Activated GPIIb-IIIa Complex at 45 Days After Intervention.
123.2 mean fluorescence intensity (MFI)
Standard Error 17.6
126.7 mean fluorescence intensity (MFI)
Standard Error 17.9

Adverse Events

Clopidogrel + Aspirin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo + Aspirin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alan D. Michelson, M.D.

Children's Hospital Boston

Phone: 617-919-2116

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place