Status:
COMPLETED
Determining Genetic Role in Treatment Response to Anti-Platelet Interventions (The PAPI Study)
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Platelet Aggregation Inhibitors
Coronary Heart Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
One of the most common ways for preventing coronary heart disease (CHD) is to take aspirin or clopidogrel. However, studies have shown that not all people respond to these medications. The variance in...
Detailed Description
CHD is the leading cause of death in the United States. Anti-platelet agents lessen platelet aggregation and are used commonly to prevent recurrent CHD events. Two of the most common anti-platelet age...
Eligibility Criteria
Inclusion
- Of Old Order Amish descent
Exclusion
- Currently pregnant or less than 6 months have passed since delivery
- Has a history of a bleeding disorder or major spontaneous bleed, such as peptic ulcer, epistasis, or intracranial bleed
- Has severe hypertension, defined by a blood pressure above 160/95 mm Hg, making it unethical not to recommend prompt treatment
- Takes medications that would affect the outcome(s) to be measured and cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation
- Is taking vitamins or other supplements and is unwilling to discontinue their use for at least 1 week prior to study
- Has a coexisting malignancy
- Has a creatinine level greater than 2.0 mg/dl, aspartate transaminase (AST) or alanine transaminase (ALT) greater than two times the upper limit of normal, hematocrit less than 32%, or a thyroid-stimulating hormone (TSH) less than 0.4 or greater than 5.5 mIU/L
- Has a bleeding disorder or history of gastrointestinal bleeding or other major bleeding episode
- Is currently taking aspirin, clopidogrel, or other anti-coagulant, such as warfarin, heparin, or GPIIb/IIIa antagonists, and have conditions that might place them at increased risk from withdrawal of these medications 14 days prior to protocol initiation, including history of unstable angina, heart attack, angioplasty (including stent placement), coronary artery bypass surgery, atrial fibrillation, stroke or transient ischemic attacks, diabetes, or deep vein thrombosis or other thrombosis
- Has polycythemia, or thrombocytosis, defined by a platelet count greater than 500,000
- Has thrombocytopenia, defined by a platelet count less than 75,000
- Has had surgery within the last 6 months
- Has an aspirin or clopidogrel allergy
- Currently breast feeding
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
682 Patients enrolled
Trial Details
Trial ID
NCT00799396
Start Date
July 1 2006
End Date
February 1 2012
Last Update
February 24 2022
Active Locations (1)
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1
Amish Research Clinic
Lancaster, Pennsylvania, United States, 17601