Ignite Creation Date:
2024-05-06 @ 2:25 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02048228
Status:
UNKNOWN
Last Update Posted:
2014-04-11
First Post:
2014-01-27
Brief Title:
Genotyping Guided Individualized Treatment of Clopidogrel and Ticagrelor in ACS
Sponsor:
Chinese PLA General Hospital
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
Study of Clopidogrel and Ticagrelor Anti-Platelet Treatment Using an Individualized Strategy Based on Genotyping in Chinese ACS Patients
Status:
UNKNOWN
Status Verified Date:
2014-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GI-CT
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 2C192 CYP2C192 using Taqman genotyping method
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 CYP2C192 genetic variant Carriers of CYP2C192 allele were at 30 higher risk for major adverse clinical events compared to non-carriers CYP2C192 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 genotypingusing Taqman genotyping method or standard treatment CYP2C192 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
Mounting evidence suggests a crucial role for the loss-of-function CYP2C192 genetic variant Carriers of CYP2C192 allele were at 30 higher risk for major adverse clinical events compared to non-carriers CYP2C192 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 genotypingusing Taqman genotyping method or standard treatment CYP2C192 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None