- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01823185
Bedside Testing of CYP2C19 Gene for Treatment of Patients With PCI With Antiplatelet Therapy
January 20, 2016 updated by: Imam Abdulrahman Bin Faisal University
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
1500
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amein K Al-Ali, PhD
- Phone Number: +966505821693
- Email: ameinomran@hotmail.com
Study Contact Backup
- Name: Abdullah M Al-Rubaish, MD
- Phone Number: +966 505 874722
- Email: arubaish@ud.edu.sa
Study Locations
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Al-Hasa, Saudi Arabia, 31982
- Recruiting
- Prince Sultan Cardiac Center
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Sub-Investigator:
- Abdullah Alabdulgader, MD
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Al-Khobar, Saudi Arabia, 31441
- Recruiting
- King Fahd University Hospital
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Principal Investigator:
- Abdullah M Al-Rubaish, MD
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Sub-Investigator:
- Fahd A Al-Muhanna, MD
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Sub-Investigator:
- Emmanuel Larbi, MD, PhD
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Sub-Investigator:
- Abdullah Al-Shehri, MD
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Sub-Investigator:
- Akram Al-Khadra, MD
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Sub-Investigator:
- Amein Al-Ali, PhD
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Sub-Investigator:
- Mohammed Al-Mansory, MD
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Dammam, Saudi Arabia, 31463
- Recruiting
- Saud Al-Babtain Cardiac Center
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Sub-Investigator:
- Hamid Al-Omran, MD
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Sub-Investigator:
- Mustafa Al-Refaei, MD
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Sub-Investigator:
- Najeeb Abdulhamid, MD
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Sub-Investigator:
- Shukry Mirza, MD
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Sub-Investigator:
- Yousef Alsabeet, MD
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Dammam, Saudi Arabia, 31932
- Recruiting
- King Fahd Military Medical Complex
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Sub-Investigator:
- Khalid Al-Fraiedi, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Clopidogrel
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.
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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.
Other Names:
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Experimental: 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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardiovascular event
Time Frame: 1 year
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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.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 30 days and 1 year
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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
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30 days and 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Abdullah M Al-Rubaish, MD, Imam Abdulrahman Bin Faisal University
- Study Director: Amein K Al-Ali, PhD, Imam Abdulrahman Bin Faisal University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Anticipated)
January 1, 2016
Study Completion (Anticipated)
March 1, 2016
Study Registration Dates
First Submitted
March 19, 2013
First Submitted That Met QC Criteria
April 2, 2013
First Posted (Estimate)
April 4, 2013
Study Record Updates
Last Update Posted (Estimate)
January 22, 2016
Last Update Submitted That Met QC Criteria
January 20, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pain
- Neurologic Manifestations
- Embolism and Thrombosis
- Myocardial Infarction
- Infarction
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Cardiovascular Diseases
- Vascular Diseases
- Embolism
- Chest Pain
- Thrombosis
- Angina Pectoris
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
- Clopidogrel
- Prasugrel Hydrochloride
Other Study ID Numbers
- STGUD005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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