CLOPIDOGREL, POOR METABOLISM of (Disorder) | Genotyping Guided Individualized Treatment of Clopidogrel and Ticagrelor in ACS
CLOPIDOGREL, POOR METABOLISM of (Disorder) research study
What is the primary objective of this study?
Clopidogrel, in addition to aspirin, is the cornerstone of therapy in patients suffering from Acute coronary syndrome. However, the platelet inhibitory response to clopidogrel varies substantially among individuals. Several loss‐of‐function polymorphisms have been identified that may influence clinical outcome in patients presenting with acute coronary syndromes (ACS) who are treated with clopidogrel. However their contribution to high on-treatment platelet reactivity (HPR) in clopidogrel treated Chinese patients is less known. As far as we know, ticagrelor is not dependent on gene-based metabolic activation and demonstrated greater clinical efficacy than clopidogrel in a recent secondary prevention trial. we will conduct an interventional study to compare the antiplatelet efficiency between clopidogrel and ticagrelor by the guidance of CYP450 2C19*2 (CYP2C19*2) , using Taqman genotyping method.
Who is eligible to participate?
Inclusion Criteria: The diagnosis of ACS including unstable angina (UA),non-ST elevation myocardial infarction(NSTEMI),and ST-elevation MI (STEMI) is according to the American Heart Association/American College of Cardiology (AHA/ACC) criteria Exclusion Criteria: known contraindication to dual anti-platelet therapy, history of chronic inflammatory disease, steroidal and non-steroidal anti-inflammatory drugs use, previous administration of antiplatelet drugs within 1 month before coronary artery angiography, illicit drug abuse, significant bleeding, cerebrovascular event within 3months, and/or major surgery within 4 weeks.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
CLOPIDOGREL, POOR METABOLISM of (Disorder)
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:genotyping guided therapy Ticagrelor, ClopidogrelCYP2C19*2 carriers will be given 90 mg ticagrelor twice daily, and non-carriers and patients in the standard treatment group will be given 75 mg clopidogrel daily.
Drug:standard therapy clopidogrelAll patients will be administrated with clopidogrel 75 mg daily for 5 consecutive days.
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.
genotyping guided therapyPatients randomized to the genotyping guided therapy arm will have their CYP2C19*2 carrier status determined at the time before antiplatelet therapy with subsequent alteration in antiplatelet therapy for *2 carriers.CYP2C19*2 carriers will be given 90 mg ticagrelor twice daily, and non-carriers will be given 75 mg clopidogrel daily.
Standard TherapyPatients randomized to the Standard Therapy arm will not undergo genotyping. All patients will be administrated with clopidogrel 75 mg daily for 5 consecutive days.
Start Date: October 2014
Completed Date: August 2016
Phase: Phase 2/Phase 3
Primary Outcome: Clopidogrel response status as measured by the LTA assay in CYP2C19*2 carriers.
Study sponsors, principal investigator, and references
Principal Investigator: Tong Yin, MD, PhD
Lead Sponsor: Chinese PLA General Hospital