drugset / Trial / NCT01823185
Bedside Testing of CYP2C19 Gene for Treatment of Patients With PCI With Antiplatelet Therapy
Phase 4
Unknown
1500 enrolled
Imam Abdulrahman Bin Faisal University
Dammam Central Hospital · collabKing Fahad Armed Forces Hospital · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clopidogrel | Small molecule | 75 mg | — |
| Subject | Prasugrel | Small molecule | 5 mg | — |
| Subject | Prasugrel | Small molecule | 10 mg | — |
| Subject | Ticagrelor | Small molecule | 90 mg | — |