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

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dammam University
• Collaborators: Dammam Central Hospital; King Fahad Armed Forces Hospital
• Treatments: Clopidogrel; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Purinergic P2 Receptor Antagonists; Ticagrelor; Ticlopidine

Criteria

Male & female age 18-70 years

Inclusion Criteria:

• Patient presents with acute myocardial infarction of more than 30 minutes and less than 12 hours

• Patient eligible for PCI

Exclusion Criteria:

• Life expectancy of less than one year

• Previously Known genotype

• Receiving chemotherapy for malignancy

• On dialysis or receiving immunosuppressive therapy or have autoimmune disease

• Hepatic impairment

• History of bleeding diathesis

• Receiving vitamin K antagonist therapy

• Confirmed hypertension

• Out of normal range platelet count

• History of major surgery

• Severe trauma or fracture

• Pregnancy and lactation

• Concomitant use of simvastatin, cytochrome P450 3A4 inhibitors or inducers

• Hypersensitivity to clopidogrel or ticagrelor or prasugrel