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

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.

Conditions

• Coronary Artery Disease
• Myocardial Infarction
• Heart Disease
• Vascular Disease
• Angina Pectoris
• Cardiovascular Disease
• Ischemia
• Infarction
• Embolism
• Thrombosis
• Chest Pain

Interventions

DRUG

clopidogrel

Genotyping will be carried out using Spartan genotyping System on all intervention group and those patients who do not carry the CYP2C19 allele 2 or 3 will be given clopidogrel (75 mg per day) while all patients who carry the CYP2C19 allele 2 or 3 will be prescribed 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) according to local protocol.

DRUG

Ticagrelor or prasugrel

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) according to local protocol.

Sponsors & Collaborators

• King Fahad Armed Forces Hospital

  collaborator OTHER_GOV

• Dammam Central Hospital

  collaborator OTHER

• Imam Abdulrahman Bin Faisal University

  lead OTHER

Principal Investigators

• Abdullah M Al-Rubaish, MD · Imam Abdulrahman Bin Faisal University

• Amein K Al-Ali, PhD · Imam Abdulrahman Bin Faisal University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2016-01-31

Completion

2016-03-31

Countries

• Saudi Arabia

Study Locations