- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02048228
Genotyping Guided Individualized Treatment of Clopidogrel and Ticagrelor in ACS (GI-CT)
Study of Clopidogrel and Ticagrelor Anti-Platelet Treatment Using an Individualized Strategy Based on Genotyping in Chinese ACS Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Tong Yin, MD, PhD
- Phone Number: +86-13693693085
- Email: yintong2000@yahoo.com
Study Locations
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Beijing, China, 100853
- General Hospital of Chinese People's Liberation Army
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Contact:
- Tong Yin, MD, PhD
- Phone Number: +86-13693693085
- Email: yintong2000@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
Other Names:
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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.
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All patients will be administrated with clopidogrel 75 mg daily for 5 consecutive days.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clopidogrel response status as measured by the LTA assay in CYP2C19*2 carriers.
Time Frame: Day 5 of enrollment
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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.
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Day 5 of enrollment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tong Yin, MD, PhD, Institute of Geriatric Cardiology, General Hospital of Chinese People's Liberation
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCT01417884
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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