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Trial record 4 of 1050 for:    clopidogrel

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
Sponsor:
Information provided by (Responsible Party):
Tong Yin, Chinese PLA General Hospital

Brief Summary:
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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • Ticagrelor
  • Clopidogrel

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Contacts
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Contact: Tong Yin, MD, PhD +86-13693693085 yintong2000@yahoo.com

Locations
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China
General Hospital of Chinese People's Liberation Army Not yet recruiting
Beijing, China, 100853
Contact: Tong Yin, MD, PhD    +86-13693693085    yintong2000@yahoo.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Tong Yin, MD, PhD Institute of Geriatric Cardiology, General Hospital of Chinese People's Liberation

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Responsible Party: Tong Yin, MD, PhD, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02048228     History of Changes
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: April 11, 2014
Last Verified: April 2014
Keywords provided by Tong Yin, Chinese PLA General Hospital:
Clopidogrel,
Pharmacogenetics,
Platelet reactivity,
CYP2C19,
point-of-care
Additional relevant MeSH terms:
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Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs