Ignite Creation Date:
2024-05-06 @ 2:12 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01990989
Status:
UNKNOWN
Last Update Posted:
2013-11-25
First Post:
2013-11-18
Brief Title:
Clopidogrel Pharmacogenetic Score System
Sponsor:
Chinese PLA General Hospital
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
Clopidogrel Pharmacogenetic Score System Established for Chinese Patients
Status:
UNKNOWN
Status Verified Date:
2013-11
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:
CPASS
Brief Summary:
The aim of the present study is to evaluate candidate variablesincluding Cytochrome P450 2C19CYP2C19 genotypes clinical and demographic variablesto establish a simple risk score that can be easily adopted by clinicians to identify patients who are at risk for HPR and composite cardiovascular outcomes in Chinese Han patients treated with dual antiplatelet therapy
Detailed Description:
There is a large inter-individual variability of biological antiplatelet responsiveness in patients treated with clopidogrel Our previous study suggested that in clopidogrel treated Chinese patients with acute coronary syndromesACScarriers of at least one CYP2C19 loss-of-function allele could predict greater risk of high on-treatment platelet reactivity HPR with the impact mainly attributing to CYP2C192 But as we know CYP2C192 could only explain a small proportion of the variability Various clinical and demographic variables have been considered to influence response to antiplatelet therapy
Study objectives
The present study aims to evaluate candidate variablesincluding CYP2C19 gene polymorphisms clinical and demographic variablesto establish a simple risk score to identify patients who are at risk for HPR and composite cardiovascular outcomes
Study design
Step 1 Population enrollment and medication This mono-center study will be conducted in General Hospital of Chinese Peoples Liberation Army Consecutive patients more than 18 years old admitted for ACS will be recruited after giving informed consents After admission all enrolled patients will be treated with 100 mg aspirin and 75mg clopidogrel per day A loading dose of 300 mg clopidogrel will be given to patients undergoing coronary angiography
Step 2 Clinical and demographic data collection A detailed demographic and medical data will be extracted from medical charts and prescription records For the development of the risk score system we will chose variables that are available in routine clinical practice Clinical candidate variables include smoking history diabeteshypertension renal failure with a serum creatinine15mgdL-1 hypercholesterolemia left ventricular dysfunction age gender acute coronary syndrome on admission and co-medication with statins calcium channel inhibitor and proton pump inhibitors
Step 3 Platelet function measurements and Genotyping After 5 days maintenance dose of clopidogrel administration blood samples will be drawn for light transmittance aggregometry LTA testing using an APACT-4 aggregometer LABiTec Germany The magnitude of on-treatment platelet reactivity was quantified using LTA with 20µmolL ADPadenosine disphosphate as the agonist Aggregation was expressed as the maximal percentage change in light transmittance from baseline with platelet-poor plasma as the reference
Genomic DNA will be extracted from the peripheral blood leucocytes of each patient The loss of function alleles CYP2C192 rs4244285 and CYP2C193 rs4986893 will be genotyped by the polymerase chain reactionPCR-ligase detection reactionsLDRsequencing method
Step 4 Follow-up At one year the incidence of composite cardiovascular outcomes will be assessed by review of the patientscharts on re-admission or by telephone interview Telephone interviewers are blinded with respect to the results of platelet aggregation and genotypes
Step 5 Statistical analysis and development of risk score Logistic regression and Cox proportional hazards survival regression will be used to develop the risk score system with the candidate variables including clinical and demographic variables CYP2C19 genotypes and platelet aggregation
Study objectives
The present study aims to evaluate candidate variablesincluding CYP2C19 gene polymorphisms clinical and demographic variablesto establish a simple risk score to identify patients who are at risk for HPR and composite cardiovascular outcomes
Study design
Step 1 Population enrollment and medication This mono-center study will be conducted in General Hospital of Chinese Peoples Liberation Army Consecutive patients more than 18 years old admitted for ACS will be recruited after giving informed consents After admission all enrolled patients will be treated with 100 mg aspirin and 75mg clopidogrel per day A loading dose of 300 mg clopidogrel will be given to patients undergoing coronary angiography
Step 2 Clinical and demographic data collection A detailed demographic and medical data will be extracted from medical charts and prescription records For the development of the risk score system we will chose variables that are available in routine clinical practice Clinical candidate variables include smoking history diabeteshypertension renal failure with a serum creatinine15mgdL-1 hypercholesterolemia left ventricular dysfunction age gender acute coronary syndrome on admission and co-medication with statins calcium channel inhibitor and proton pump inhibitors
Step 3 Platelet function measurements and Genotyping After 5 days maintenance dose of clopidogrel administration blood samples will be drawn for light transmittance aggregometry LTA testing using an APACT-4 aggregometer LABiTec Germany The magnitude of on-treatment platelet reactivity was quantified using LTA with 20µmolL ADPadenosine disphosphate as the agonist Aggregation was expressed as the maximal percentage change in light transmittance from baseline with platelet-poor plasma as the reference
Genomic DNA will be extracted from the peripheral blood leucocytes of each patient The loss of function alleles CYP2C192 rs4244285 and CYP2C193 rs4986893 will be genotyped by the polymerase chain reactionPCR-ligase detection reactionsLDRsequencing method
Step 4 Follow-up At one year the incidence of composite cardiovascular outcomes will be assessed by review of the patientscharts on re-admission or by telephone interview Telephone interviewers are blinded with respect to the results of platelet aggregation and genotypes
Step 5 Statistical analysis and development of risk score Logistic regression and Cox proportional hazards survival regression will be used to develop the risk score system with the candidate variables including clinical and demographic variables CYP2C19 genotypes and platelet aggregation
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