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Coronary Artery Disease | Role of CYP2C19 Polymorphism in the Drug Interaction Between Clopidogrel and Omeprazole

Coronary Artery Disease research study

What is the primary objective of this study?

Clopidogrel, an inhibitor of ADP induced platelet aggregation and activation, is one of the most commonly used drugs in patients with cardiovascular disease. The specific aim of the proposed study is to determine whether the interaction between proton-pump inhibitors (PPIs) and clopidogrel is dependent on CYP2C19 haplotype.

Who is eligible to participate?

Inclusion Criteria: - age 18- 65 - healthy - not taking any drugs / over the counter drugs regularly. - ability and commitment to take the drugs and volunteer for 3 blood draws. Exclusion Criteria: - Taking any scheduled medication known to affect platelet function such as clopidogrel or NSAIDS11, COX2 inhibitors, beta blockers, calcium channel blockers, diuretics, anti-coagulants, older psychotropic agents, and recent ingestion of alcohol and caffeine - Known history of heart disease - Bleeding disorders - Known allergy or contraindications to omeprazole or clopidogrel - Pregnant and nursing women will also be excluded.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Coronary Artery Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Clopidogrel 75mg, Omeprazole 20mgClopidogrel and or Omeprazole as applicable

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

wild / normal type allele of CYP2C geneclopidogrel 75 mg alone.

wild / normal type allele of CYP2Cclopidogrel 75 mg + omeprazole 20 mg.

Loss of Haplotype CYP2C19clopidogrel 75mg alone

Loss of function haplotype of CYP2Cclopidogrel 75mg + omerprazole 20mg.

Study Status

Recruiting

Start Date: January 2010

Completed Date: August 2017

Phase: Phase 4

Type: Observational [Patient Registry]

Design:

Primary Outcome: To test whether concomitant administration of omeprazole will decrease the platelet inhibitory properties of clopidogrel in subjects with loss of function (LOF) mutation of CYP2C19 (known as *2 and *3).

Secondary Outcome: To test whether concomitant administration of omeprazole will decrease the conversion of clopidogrel to its active metabolite in subjects with loss of function (LOF) mutation of CYP2C19 (known as *2 and *3).

Study sponsors, principal investigator, and references

Principal Investigator: Neal S Kleiman, MD

Lead Sponsor: Neil Kleiman, MD

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01094275

Discuss Omeprazole