Bedside Testing of CYP2C19 Gene for Treatment of Patients With PCI With Antiplatelet Therapy
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01823185|
Recruitment Status : Unknown
Verified January 2016 by Dammam University.
Recruitment status was: Recruiting
First Posted : April 4, 2013
Last Update Posted : January 22, 2016
|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||March 2016|
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.
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.
- 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.
- 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
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
|Contact: Amein K Al-Ali, PhDfirstname.lastname@example.org|
|Contact: Abdullah M Al-Rubaish, MD||+966 505 email@example.com|
|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|
|Principal Investigator:||Abdullah M Al-Rubaish, MD||Imam Abdulrahman Bin Faisal University|
|Study Director:||Amein K Al-Ali, PhD||Imam Abdulrahman Bin Faisal University|