NCT01761786

Cost-effectiveness of Genotype Guided Treatment With Antiplatelet Drugs in STEMI Patients: Optimization of Treatment (POPular Genetics)

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).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,700 (actual)
• Sponsor: Vera HM Deneer · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction
• STEMI

Interventions

Type	Name	Description
GENETIC	CYP2C19 genotyping	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.

Timeline

• Start date: 2011-06-01
• Primary completion: 2019-04-04
• Completion: 2019-04-04
• First posted: 2013-01-07
• Last updated: 2019-05-10

Locations

10 sites across 3 countries: Belgium, Italy, Netherlands