drugset / Trial / NCT01823185

Bedside Testing of CYP2C19 Gene for Treatment of Patients With PCI With Antiplatelet Therapy

NCT01823185

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Clopidogrel is crucial as antiplatelet treatment in patients undergoing percutaneous coronary intervention (PCI) with stent implantation and during one year after PCI, to prevent atherothrombotic complications. However, clopidogrel is ineffective in certain patients due to genetic mutation in CYP2C19 gene a specific enzyme in the liver required for metabolism of clopidogrel. Therefore, the purpose of this study is to test these patients genetically at bedside and prescribe an alternative drug such as Ticagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight \< 60kg) if they are carriers of the allele 2 or 3 of the mutated gene.

Timeline

Start
2013-03
Primary completion
2016-01
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clopidogrel Small molecule 75 mg
Subject Prasugrel Small molecule 5 mg
Subject Prasugrel Small molecule 10 mg
Subject Ticagrelor Small molecule 90 mg