Comparison of Triflusal and Clopidogrel in Secondary Prevention of Stroke Based on the Genotyping

Cerebral Infarction Clinical Trial

— MAESTRO  

Official title:

Comparison of Triflusal and Clopidogrel Effect in Secondary Prevention of Stroke Based on the Cytochrome P450 2C19 Genotyping

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174693
• Other study ID #: MAESTRO-001
• Status: Completed
• Phase: Phase 4
• First received: August 3, 2010
• Last updated: March 16, 2015
• Start date: March 2010
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the preventive effect of stroke between triflusal and clopidogrel in ischemic stroke patient based on the cytochrome P450 2C19 (CYP2C19) polymorphism.

Description:

Clopidogrel has anti-platelet activity by irreversible inhibition of the P2Y12 platelet receptor. Clopidogrel must be converted into an active metabolite in order to show anti-platelet activity. Hepatic CYP2C19 enzyme is one of the key hepatic enzymes which convert clopidogrel into active metabolite and its genetic polymorphism is related to clopidogrel resistance. CYP2C19 poor or intermediate metabolizer groups show reduced anti-platelet activity of clopidogrel compared to extensive metabolizer group.

This study is designed to prove the superiority of the triflusal in preventing recurrent stroke over the clopidogrel in ischemic stroke patient with poor or intermediate metabolizer of CYP2C19 polymorphism. Also we plan to prove that clopidogrel resistance is related to CYP2C19 polymorphism by comparing the ischemic preventive effect of clopidogrel between groups of different CYP2C19 polymorphism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 795
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients who have non-cardiogenic ischemic stroke of TOAST classification within 30 days prior to screening

2. = 20 years of age; adult, at the date of signing the informed consent

3. Written informed consent

Exclusion Criteria:

1. History for bleeding tendency or recent major bleeding within 2 weeks

2. Chronic liver disease (ALT > 100 IU/L or AST > 100 IU/L) or renal dysfunction (creatinine > 4.0 mg/dl)

3. Thrombocytopenia (platelet < 100,000mm3)

4. Any contraindication of antiplatelet agent

5. Severe congestive heart failure

6. Patients who need to take anticoagulants or two or more antiplatelet agents

7. Severe concomitant disease with the expected survival less than 2 years

8. Pregnant or nursing

9. Any drug clinical trials within 30 days of signing the informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction

Intervention

Drug:
• Triflusal
Dose: 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014
• Clopidogrel
Dose: 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014

Locations

Country	Name	City	State
Korea, Republic of	Changwon Fatima Hospital	Changwon	Gyeongsangnam-do
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Department of Neurology, Konyang University Hospital	Daejeon
Korea, Republic of	Department of Neurology, National Health Insurance Corporation Ilsan Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Department of Neurology, Chosun University Hospital	Gwangju
Korea, Republic of	Department of Neurology, CHA Bundang Medical Center, CHA University School of Medicine	Seongnam-si	Gyeonggi-do
Korea, Republic of	Department of Neurology, Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Department of Neurology, Gangnam Severance Hospital, Yonsei Univ. College of Medicine	Seoul
Korea, Republic of	Department of Neurology, Korea University Guro Hospital	Seoul
Korea, Republic of	Department of Neurology, Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Department of Neurology, National Medical Center	Seoul
Korea, Republic of	Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine	Seoul
Korea, Republic of	Department of Neurology, Severance Hospital, Yonsei University College of Medicine	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	KyungHee University Medical Center	Seoul
Korea, Republic of	Department of Neurology, Wonju Christian Hospital, Yonei University Wonju College of Medicine	Wonju-si	Gangwon-do

Sponsors (3)

Lead Sponsor	Collaborator
Gangnam Severance Hospital	Myung In Pharmaceutical Company, Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first recurrent stroke	The study will finish at least 2 years after the recruit of 1080th patients. Until the finish, patients will continuously take study medications and visit every 3months at the study site.; We will measure primary outcome during the follow-up period (minimum 2.8 years to maximum 4 years - maximum time is determined by estimated enrollment time period of 2.8 years).	2.8 to 4 years	No
Secondary	Time to first of composite cardiovascular events, MI or coronary artery revascularization and ischemic stroke	The study will finish at least 2 years after the recruit of 1080th patients. Until the finish, patients will continuously take study medications and visit every 3months at the study site.; We will measure secondary outcomes during the follow-up period (minimum 2.8 years to maximum 4 years - maximum time is determined by estimated enrollment time period of 2.8 years).	2.8 to 4 years	No