Clinical trial NCT01174693: Comparison of Triflusal and Clopidogrel in Secondary Prevention of Stroke Based on the Genotyping
Official title: Comparison of Triflusal and Clopidogrel Effect in Secondary Prevention of Stroke Based on the Cytochrome P450 2C19 Genotyping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebral Infarction
Keywords: prospective
randomized
open label
multi-center
double-blind for CYP2C19 genotypes
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
Collaborators: name: Myung In Pharmaceutical Company
name: Yonsei University
First posted: 2010-08-04
Enrollment: 795
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to first recurrent stroke
timeFrame: 2.8 to 4 years
Secondary outcomes:
measure: Time to first of composite cardiovascular events, MI or coronary artery revascularization and ischemic stroke
timeFrame: 2.8 to 4 years
Other outcomes:
Locations:
city: Wonju-si
country: Korea, Republic of
facility: Department of Neurology, Wonju Christian Hospital, Yonei University Wonju College of Medicine
state: Gangwon-do
city: Goyang-si
country: Korea, Republic of
facility: Department of Neurology, National Health Insurance Corporation Ilsan Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Department of Neurology, CHA Bundang Medical Center, CHA University School of Medicine
state: Gyeonggi-do
city: Changwon
country: Korea, Republic of
facility: Changwon Fatima Hospital
state: Gyeongsangnam-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Daejeon
country: Korea, Republic of
facility: Department of Neurology, Konyang University Hospital
city: Gwangju
country: Korea, Republic of
facility: Department of Neurology, Chosun University Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Neurology, National Medical Center
city: Seoul
country: Korea, Republic of
facility: Department of Neurology, Severance Hospital, Yonsei University College of Medicine
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Department of Neurology, Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Department of Neurology, Gangnam Severance Hospital, Yonsei Univ. College of Medicine
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Department of Neurology, Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Neurology, Ewha Womans University Mokdong Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: KyungYul Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han SW, Kim YJ, Ahn SH, Seo WK, Yu S, Oh SH, Kim YN, Lee KY; MAESTRO Study Investigators. Protocol for the comparison of triflusal and clopidogrel in secondary prevention of stroke based on cytochrome P450 2C19 genotyping (MASETRO study): A multicenter, randomized, open-label, parallel-group trial. Int J Stroke. 2016 Jun;11(4):485-91. doi: 10.1177/1747493015620804. Epub 2016 Jan 5.