Genotyping Guided Individualized Treatment of Clopidogrel and Ticagrelor in ACS (GI-CT)
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|ClinicalTrials.gov Identifier: NCT02048228|
Recruitment Status : Unknown
Verified April 2014 by Tong Yin, Chinese PLA General Hospital.
Recruitment status was: Not yet recruiting
First Posted : January 29, 2014
Last Update Posted : April 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|CLOPIDOGREL, POOR METABOLISM of (Disorder)||Drug: genotyping guided therapy Ticagrelor, Clopidogrel Drug: standard therapy clopidogrel||Phase 2 Phase 3|
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.
Mounting evidence suggests a crucial role for the loss-of-function CYP2C19*2 genetic variant. Carriers of CYP2C19*2 allele were at 30% higher risk for major adverse clinical events compared to non-carriers. CYP2C19*2 alone was also associated with increased mortality and stent thrombosis. These findings led the American Food and Drug Administration to issue a boxed warning for clopidogrel stating that poor metabolizers may not receive the full benefit of the drug. Thus, routine genotyping in the context of dual anti-platelet therapy is necessary.
Individual dual anti-platelet treatment is feasible to give the presence of treatment alternatives such as ticagrelor that is not dependent on gene-based metabolic activation and demonstrated greater clinical efficacy than clopidogrel. Individualized administration of ticagrelor may have the potential to successfully minimize adverse ischemic events.
200 patients undergoing percutaneous coronary intervention (PCI) for treatment of non-ST-elevation acute coronary syndrome or stable coronary artery disease will be eligible for enrollment. Patients will be randomly assigned to a strategy of genotyping(using Taqman genotyping method) or standard treatment . CYP2C19*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. At the end of the 5 day antiplatelet treatment, efficacy of the treatment strategies will be evaluated using light transmittance aggregometry (LTA) method.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Clopidogrel and Ticagrelor Anti-Platelet Treatment Using an Individualized Strategy Based on Genotyping in Chinese ACS Patients|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||August 2016|
Experimental: genotyping guided therapy
Patients 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.
Drug: genotyping guided therapy Ticagrelor, Clopidogrel
CYP2C19*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.
Active Comparator: Standard Therapy
Patients randomized to the Standard Therapy arm will not undergo genotyping. All patients will be administrated with clopidogrel 75 mg daily for 5 consecutive days.
Drug: standard therapy clopidogrel
All patients will be administrated with clopidogrel 75 mg daily for 5 consecutive days.
Other Name: clopidogrel
- Clopidogrel response status as measured by the LTA assay in CYP2C19*2 carriers. [ Time Frame: Day 5 of enrollment ]The primary endpoint is the proportion of CYP2C19*2 carriers with a platelet aggregation more than 59% after 5 days of antiplatelet therapy.The deﬁnition of high on-treatment platelet reactivity is derived from previous studies that had identiﬁed platelet aggregation more than 59% as optimum cutoff values for prediction of increased risk of major adverse cardiovascular events in Chinese patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048228
|Contact: Tong Yin, MD, PhDfirstname.lastname@example.org|
|General Hospital of Chinese People's Liberation Army||Not yet recruiting|
|Beijing, China, 100853|
|Contact: Tong Yin, MD, PhD +86-13693693085 email@example.com|
|Principal Investigator:||Tong Yin, MD, PhD||Institute of Geriatric Cardiology, General Hospital of Chinese People's Liberation|