A Phase 4 interventional study of clopidogrel and Ticagrelor or prasugrel in Coronary Artery Disease, Myocardial Infarction and Heart Disease, sponsored by Imam Abdulrahman Bin Faisal University. Status unknown at 4 sites in Saudi Arabia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-01-22.
Sponsored by Imam Abdulrahman Bin Faisal University · Phase 4, Interventional, and Treatment
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.
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. Clopidogrel is converted into its active metabolite by Cytochrome P2C19 (CYP2C19). However 30 % of the Saudi population is carrier of the non functional CYP2C19*2 or *3 alleles having an impaired CYP2C19 capacity, resulting in decreased effectiveness of Clopidogrel. These patients have a 42% higher risk for major cardiovascular events (MACE) compared to non carriers. Further 50 % of the MACE occurs in the first 48 hours. Therefore 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) whose actions are not dependent on conversion by CYP2C19 may be an alternative only in carriers of the non functional CYP2C19*2 or *3 alleles. This might be cost effective and prevent patients form MACE. Therefore the objective of this study is to assess the efficacy, complication free survival, safety and cost-effectiveness of the CYP2C19 genotype guided antiplatelet treatment strategy, using clopidogrel or prasugrel (or Ticlid). All participants will be followed for one year using follow up questionnaires.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Imam Abdulrahman Bin Faisal University is the lead sponsor of 90 studies on the registry; 14 are open to participants now.
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Male \& female age 18-70 years
Inclusion Criteria:
Exclusion Criteria:
CYP2C19 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.
Drug: clopidogrel
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
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.
Also known as: Clavix
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.
Also known as: Brilinta, Prasuvas
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.
Time frame: 1 year
Mortality
Secondary efficacy endpoints are the number of patients who either died , died from cardiovascular death, from cerebrovascular death, developed recurrent MI, stent thrombosis, underwent urgent target vessel revascularization, developed stroke or combination of above
Time frame: 30 days and 1 year
The record gives a start of Mar 2013, a primary completion of Jan 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ticagrelor
Imam Abdulrahman Bin Faisal University