drugset / Trial / NCT01341600
Clopidogrel Pharmacogenetics (PGX) Bench to Bedside
Completed
18 enrolled
University of Maryland, Baltimore
Food and Drug Administration (FDA) · collabNational Cancer Institute (NCI) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabNational Institute of General Medical Sciences (NIGMS) · collab
Non-randomizedCrossoverOpen-labelTreatment
Summary
Clopidogrel (also known as Plavix) is used commonly in patients to prevent heart attacks and conditions caused by blood clots. Although clopidogrel works in many individuals, some people do not respond as well to this drug. The variation in treatment response may be linked to genetics. This study will examine the effects of clopidogrel in a population in which sequencing for certain genes has been performed in order to determine the role that genes play in the response to various clopidogrel maintenance doses.
Timeline
- Start
- 2010-07
- Primary completion
- 2011-05
- Completion
- 2011-05
Publications
- Background 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 effect and clinical efficacy of clopidogrel therapy. JAMA. 2009 Aug 26;302(8):849-57. doi: 10.1001/jama.2009.1232.
- Background Jiang XL, Samant S, Lewis JP, Horenstein RB, Shuldiner AR, Yerges-Armstrong LM, Peletier LA, Lesko LJ, Schmidt S. Development of a physiology-directed population pharmacokinetic and pharmacodynamic model for characterizing the impact of genetic and demographic factors on clopidogrel response in healthy adults. Eur J Pharm Sci. 2016 Jan 20;82:64-78. doi: 10.1016/j.ejps.2015.10.024. Epub 2015 Oct 30.
- Background Horenstein RB, Madabushi R, Zineh I, Yerges-Armstrong LM, Peer CJ, Schuck RN, Figg WD, Shuldiner AR, Pacanowski MA. Effectiveness of clopidogrel dose escalation to normalize active metabolite exposure and antiplatelet effects in CYP2C19 poor metabolizers. J Clin Pharmacol. 2014 Aug;54(8):865-73. doi: 10.1002/jcph.293. Epub 2014 Apr 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clopidogrel | Small molecule | 75 mg | — |
| Subject | Clopidogrel | Small molecule | 150 mg | — |
| Subject | Clopidogrel | Small molecule | 300 mg | — |
| Subject | Omeprazole | Other / unclassified | 20 mg | — |
Indications
No indication recorded.