Coronary Heart Disease Clinical Trial
Official title:
Pharmacogenomics of Anti-Platelet Interventions (The PAPI Study)
Verified date | February 2022 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 682 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Of Old Order Amish descent Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Amish Research Clinic | Lancaster | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore | National Heart, Lung, and Blood Institute (NHLBI), National Institute of General Medical Sciences (NIGMS) |
United States,
Bozzi LM, Mitchell BD, Lewis JP, Ryan KA, Herzog WR, O'Connell JR, Horenstein RB, Shuldiner AR, Yerges-Armstrong LM. The Pharmacogenomics of Anti-Platelet Intervention (PAPI) Study: Variation in Platelet Response to Clopidogrel and Aspirin. Curr Vasc Phar — View Citation
Lewis JP, Fisch AS, Ryan K, O'Connell JR, Gibson Q, Mitchell BD, Shen H, Tanner K, Horenstein RB, Pakzy R, Tantry US, Bliden KP, Gurbel PA, Shuldiner AR. Paraoxonase 1 (PON1) gene variants are not associated with clopidogrel response. Clin Pharmacol Ther. — View Citation
Lewis JP, Horenstein RB, Ryan K, O'Connell JR, Gibson Q, Mitchell BD, Tanner K, Chai S, Bliden KP, Tantry US, Peer CJ, Figg WD, Spencer SD, Pacanowski MA, Gurbel PA, Shuldiner AR. The functional G143E variant of carboxylesterase 1 is associated with incre — View Citation
Lewis JP, Ryan K, O'Connell JR, Horenstein RB, Damcott CM, Gibson Q, Pollin TI, Mitchell BD, Beitelshees AL, Pakzy R, Tanner K, Parsa A, Tantry US, Bliden KP, Post WS, Faraday N, Herzog W, Gong Y, Pepine CJ, Johnson JA, Gurbel PA, Shuldiner AR. Genetic va — View Citation
Lewis JP, Stephens SH, Horenstein RB, O'Connell JR, Ryan K, Peer CJ, Figg WD, Spencer SD, Pacanowski MA, Mitchell BD, Shuldiner AR. The CYP2C19*17 variant is not independently associated with clopidogrel response. J Thromb Haemost. 2013 Sep;11(9):1640-6. — View Citation
Shuldiner AR, O'Connell JR, Bliden KP, Gandhi A, Ryan K, Horenstein RB, Damcott CM, Pakyz R, Tantry US, Gibson Q, Pollin TI, Post W, Parsa A, Mitchell BD, Faraday N, Herzog W, Gurbel PA. Association of cytochrome P450 2C19 genotype with the antiplatelet e — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Platelet Function in Response to Clopidogrel | Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation. | Measured at baseline, and after clopidogrel treatment | |
Primary | Changes in Platelet Function in Response to Clopidogrel Plus Aspirin | Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation | Measured at baseline, and after clopidogrel plus aspirin treatment |
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