Status:
COMPLETED
PACT (Platelet Activity After Clopidogrel Termination)
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
Sanofi
Bristol-Myers Squibb
Conditions:
Blood Platelets
Clopidogrel
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
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 pla...
Detailed Description
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 subje...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00619073
Start Date
April 1 2008
End Date
May 1 2009
Last Update
May 31 2018
Active Locations (1)
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1
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655-0002