Bedside Testing of CYP2C19 Gene for Treatment of Patients With PCI With Antiplatelet Therapy
Bedside Testing of the CYP2C19 Gene to Asses Effectiveness of Clopidogrel in Coronary Artery Disease Patients Treated With Percutaneous Coronary Intervention : Individualized Antiplatelet Drugs Treatment to Improve Prognosis
1 other identifier
interventional
1,500
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Mar 2013
Typical duration for phase_4 coronary-artery-disease
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 19, 2013
CompletedFirst Posted
Study publicly available on registry
April 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJanuary 22, 2016
January 1, 2016
2.8 years
March 19, 2013
January 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cardiovascular event
The primary end point is the number of patients who develop adverse major cardiovascular event which include recurrent myocardial infarction, non-fatal stroke, cardiovascular mortality, severe ischemia, major bleeding at 30days after PCI.
1 year
Secondary Outcomes (1)
Mortality
30 days and 1 year
Study Arms (2)
Clopidogrel
ACTIVE COMPARATORCYP2C19 genotyping will be carried out at the end of the study period. Clopidogrel will be used for treatment for one year according to local protocol. Patients will receive clopidogrel 75 mg per day.
Ticagrelor or prasugrel
EXPERIMENTALTicagrelor (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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patient presents with acute myocardial infarction of more than 30 minutes and less than 12 hours
- Patient eligible for PCI
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imam Abdulrahman Bin Faisal Universitylead
- King Fahad Armed Forces Hospitalcollaborator
- Dammam Central Hospitalcollaborator
Study Sites (4)
Prince Sultan Cardiac center
Al-Hasa, 31982, Saudi Arabia
Saud Al-Babtain Cardiac Center
Dammam, 31463, Saudi Arabia
King Fahd Military Medical Complex
Dammam, 31932, Saudi Arabia
King Fahd University Hospital
Khobar, 31441, Saudi Arabia
Related Publications (1)
Al-Rubaish AM, Al-Muhanna FA, Alshehri AM, Al-Mansori MA, Alali RA, Khalil RM, Al Faraidy KA, Cyrus C, Sulieman MM, Vatte C, Claassens DMF, Ten Berg JM, Asselbergs FW, Al-Ali AK. Bedside testing of CYP2C19 gene for treatment of patients with PCI with antiplatelet therapy. BMC Cardiovasc Disord. 2020 Jun 3;20(1):268. doi: 10.1186/s12872-020-01558-2.
PMID: 32493215DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abdullah M Al-Rubaish, MD
Imam Abdulrahman Bin Faisal University
- STUDY DIRECTOR
Amein K Al-Ali, PhD
Imam Abdulrahman Bin Faisal University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2013
First Posted
April 4, 2013
Study Start
March 1, 2013
Primary Completion
January 1, 2016
Study Completion
March 1, 2016
Last Updated
January 22, 2016
Record last verified: 2016-01