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

This study is currently recruiting participants.
Verified January 2016 by Dammam University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01823185
First Posted: April 4, 2013
Last Update Posted: January 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
King Fahad Armed Forces Hospital
Dammam Central Hospital
Information provided by (Responsible Party):
Dammam University
  Purpose
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.

Condition Intervention Phase
Coronary Artery Disease Myocardial Infarction Heart Disease Vascular Disease Angina Pectoris Cardiovascular Disease Ischemia Infarction Embolism Thrombosis Chest Pain Drug: clopidogrel Drug: Ticagrelor or prasugrel Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dammam University:

Primary Outcome Measures:
  • cardiovascular event [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 days and 1 year ]
    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


Estimated Enrollment: 1500
Study Start Date: March 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other Name: Clavix
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.
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.
Other Names:
  • Brilinta
  • Prasuvas

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823185


Contacts
Contact: Amein K Al-Ali, PhD +966505821693 ameinomran@hotmail.com
Contact: Abdullah M Al-Rubaish, MD +966 505 874722 arubaish@ud.edu.sa

Locations
Saudi Arabia
Prince Sultan Cardiac center Recruiting
Al-Hasa, Saudi Arabia, 31982
Sub-Investigator: Abdullah Alabdulgader, MD         
King Fahd University Hospital Recruiting
Al-Khobar, Saudi Arabia, 31441
Principal Investigator: Abdullah M Al-Rubaish, MD         
Sub-Investigator: Fahd A Al-Muhanna, MD         
Sub-Investigator: Emmanuel Larbi, MD, PhD         
Sub-Investigator: Abdullah Al-Shehri, MD         
Sub-Investigator: Akram Al-Khadra, MD         
Sub-Investigator: Amein Al-Ali, PhD         
Sub-Investigator: Mohammed Al-Mansory, MD         
Saud Al-Babtain Cardiac Center Recruiting
Dammam, Saudi Arabia, 31463
Sub-Investigator: Hamid Al-Omran, MD         
Sub-Investigator: Mustafa Al-Refaei, MD         
Sub-Investigator: Najeeb Abdulhamid, MD         
Sub-Investigator: Shukry Mirza, MD         
Sub-Investigator: Yousef Alsabeet, MD         
King Fahd Military Medical Complex Recruiting
Dammam, Saudi Arabia, 31932
Sub-Investigator: Khalid Al-Fraiedi, MD         
Sponsors and Collaborators
Dammam University
King Fahad Armed Forces Hospital
Dammam Central Hospital
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
  More Information

Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT01823185     History of Changes
Other Study ID Numbers: STGUD005
First Submitted: March 19, 2013
First Posted: April 4, 2013
Last Update Posted: January 22, 2016
Last Verified: January 2016

Keywords provided by Dammam University:
Clopidogrel
Ticagrelor
Prasugrel
Platelet aggregation inhibitor
Dammam University
King Fahd Hospital
Purinergic P2 receptor Antagonists

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Myocardial Infarction
Ischemia
Thrombosis
Embolism
Vascular Diseases
Chest Pain
Angina Pectoris
Pathologic Processes
Necrosis
Arteriosclerosis
Arterial Occlusive Diseases
Embolism and Thrombosis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Clopidogrel
Ticlopidine
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Ticagrelor
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Purinergic Antagonists