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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Dammam University
Sponsor:
Collaborators:
King Fahad Armed Forces Hospital
Dammam central Hospital
Information provided by (Responsible Party):
Dammam University
ClinicalTrials.gov Identifier:
NCT01823185
First received: March 19, 2013
Last updated: April 2, 2013
Last verified: March 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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: July 2015
Estimated Primary Completion Date: May 2015 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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         
King Fahd Military Medical Complex Recruiting
Dammam, Saudi Arabia, 31932
Sub-Investigator: Khalid Al-Fraiedi, 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         
Sponsors and Collaborators
Dammam University
King Fahad Armed Forces Hospital
Dammam central Hospital
Investigators
Principal Investigator: Abdullah M Al-Rubaish, MD University of Dammam
Study Director: Amein K Al-Ali, PhD University of Dammam
  More Information

No publications provided

Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT01823185     History of Changes
Other Study ID Numbers: STGUD005
Study First Received: March 19, 2013
Last Updated: April 2, 2013
Health Authority: Saudi Arabia: Ethics Committee

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

Additional relevant MeSH terms:
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Coronary Artery Disease
Coronary Disease
Heart Diseases
Infarction
Myocardial Infarction
Myocardial Ischemia
Thrombosis
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Embolism and Thrombosis
Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Clopidogrel
Platelet Aggregation Inhibitors
Prasugrel
Purinergic P2 Receptor Antagonists
Ticagrelor
Ticlopidine
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on November 20, 2014