PACT (Platelet Activity After Clopidogrel Termination)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-05-31

Brief Summary

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Clopidogrel is a medication that is used to decrease the ability of platelets to form blood clots.

The theory has been proposed that, in patients with coronary artery disease or stroke, increased platelet function after discontinuation of clopidogrel therapy is associated with an increased clotting risk. However, this theory has never been rigorously tested.

The goal of this research is to determine whether discontinuation of clopidogrel results in increased platelet function.

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Detailed Description

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In this study, we will address the question: does discontinuation of clopidogrel result in platelet hyperreactivity? We will perform a double-blind, placebo-controlled, crossover study in normal subjects, in whom platelet reactivity will be measured before clopidogrel or placebo, during clopidogrel or placebo, and at various time points after discontinuation of clopidogrel or placebo. The dose of clopidogrel will be the standard, FDA-approved dose: 75 mg daily. All subjects will be treated with aspirin 81 mg daily throughout the 57 days of study assessment in both the clopidogrel arm and the placebo arm, because the clinically relevant question is: in patients who remain on aspirin, does discontinuation of clopidogrel result in platelet hyperreactivity?

Conditions

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Blood Platelets Clopidogrel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Clopidogrel + aspirin

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.

Group Type ACTIVE_COMPARATOR

clopidogrel + aspirin

Intervention Type DRUG

Clopidogrel 75mg plus aspirin 81mg, tablet by mouth daily for 14 days.

Aspirin

Intervention Type DRUG

Aspirin 81mg tablet by mouth continued daily alone for 43 days after day 14.

Placebo + aspirin

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo plus aspirin 81 mg, tablet by mouth daily for 14 days.

Aspirin

Intervention Type DRUG

Aspirin 81mg tablet by mouth continued daily alone for 43 days after day 14.

Interventions

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clopidogrel + aspirin

Clopidogrel 75mg plus aspirin 81mg, tablet by mouth daily for 14 days.

Intervention Type DRUG

placebo

Placebo plus aspirin 81 mg, tablet by mouth daily for 14 days.

Intervention Type DRUG

Aspirin

Aspirin 81mg tablet by mouth continued daily alone for 43 days after day 14.

Intervention Type DRUG

Other Intervention Names

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Plavix aspirin aspirin

Eligibility Criteria

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Inclusion Criteria

* Must be a normal healthy subject
* Must be between 21-70 years old
* Must be able to take aspirin and clopidogrel.
* Must be able to have blood drawn 16 times over approximately 3 months.

Exclusion Criteria

* Subject who is currently taking aspirin or another anti-platelet drug such as clopidogrel. Subject must be free of these medications for 10 days before enrolling in this study.
* Subject who is currently taking a non-steroidal anti-inflammatory drug such as ibuprofen or naproxen. Subject must be free of these medications for 3 days before enrolling in this study.
* Subject who is currently taking medications for depression or medications that lower blood pressure or lower blood sugar.
* Subject who are pregnant or may become pregnant during the study or who is breast feeding.
* Subject with a known allergy to aspirin or clopidogrel.
* Cigarette smoking or use of other nicotine product.
* Subject with a history of any of the following: coronary artery disease; stroke; bleeding disorder; ongoing bleeding; previous life-threatening hemorrhage; stomach ulcers; gastrointestinal bleeding within the past 1 month; major surgery within the past 1 month; minor surgery within the past 2 weeks; or platelet transfusion within the past 7 days.
* Subject with a blood count, measured on the pre-study drug blood sample, that is not in the normal range.
* Subject who is enrolled in another clinical trial of an investigational drug.

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes