CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,700 enrolled
Drug / intervention
CYP2C19 genotypinggenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01761786
NCT01761786Phase 4Completed

Cost-effectiveness of CYP2C19 Genotype Guided Treatment With Antiplatelet Drugs in Patients With ST-segment-elevation Myocardial Infarction Undergoing Immediate PCI With Stent Implantation: Optimization of Treatment (POPular Genetics).

Vera HM Deneer·interventional·Posted Jan 7, 2013·Updated May 10, 2019

In Brief

A Phase 4 clinical trial evaluating CYP2C19 genotyping for Myocardial Infarction and STEMI. Completed, enrolled 2,700 participants across 10 sites in 3 countries.

Detailed Summary

Rationale: the use of antiplatelet drugs (i.e. clopidogrel, ticagrelor or prasugrel) is crucial in the treatment of patients undergoing percutaneous coronary intervention (PCI) with stent implantation to prevent atherothrombotic events. Ticagrelor and prasugrel are more effective in preventing atherothrombotic events, but with a higher risk of bleeding complications, compared to clopidogrel. Clopidogrel is converted into its active metabolite by CYP2C19. Carriers of the non functional CYP2C19\*2 and \*3 alleles have an impaired CYP2C19 capacity, making clopidogrel less effective. For these subjects ticagrelor or prasugrel is an alternative. Objective: to assess the efficacy, safety and cost-effectiveness of the CYP2C19 genotype guided antiplatelet treatment strategy, using clopidogrel in non-carriers of a CYP2C19\*2 or \*3 allele and ticagrelor or prasugrel in carriers of a CYP2C19\*2 or \*3 allele in STEMI patients. Intervention: the intervention group will be genotyped for CYP2C19\*2 and \*3 allele variants within 48 hours after primary PCI. Carriers will receive either ticagrelor (90 mg twice daily) or prasugrel (10 mg once daily or 5 mg once daily if the patient is older than age 75 or has a body weight less than 60 kg), according to local standards. Non-carriers will be treated with clopidogrel (75 mg once daily). The control group receives either ticagrelor or prasugrel, according to local standards at the same dosage as the CYP2C19\*2 or \*3 carriers in the intervention group. The antiplatelet drug will be continued for one year after PCI. The follow-up duration will be one year using follow-up questionnaires.

Study Details

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 7, 2013
Enrollment StartJun 1, 2011
Primary CompletionApr 4, 2019
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 13.5 years ago

Interventions

CYP2C19 genotypinggenetic

CYP2C19 genotyping will be performed in the intervention group. In patients with \*1/\*1 genotype (Extensive Metabolizer) clopidogrel will be prescribed. All patients who are carrier of a loss-to-function (\*2 or \*3) gene allel and all patients randomized to the control group will be prescribed prasugrel or ticagrelor, according to local protocol.