Determining Genetic Role in Treatment Response to Anti-Platelet Interventions (The PAPI Study)

Completed · Phase 4

Conditions studied: Platelet Aggregation Inhibitors, Coronary Heart Disease

In brief

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 treatment response may be linked to genetics. This study will examine the effects of aspirin and clopidogrel in a population whose genes are well known in order to determine the role that genes play in treatment responses.

Key facts

Study ID

NCT00799396

Run by

University of Maryland, Baltimore

People needed

682

Starts

2006-07-01

Expected to finish

2012-02-01

Last updated by the study team

2022-02-24

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Of Old Order Amish descent

You may not qualify if…

• 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

Where it is running

• Amish Research Clinic — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

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