Comparison of Triflusal and Clopidogrel in Secondary Prevention of Stroke Based on the Genotyping
MAESTRO
1 other identifier
interventional
795
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2010
Longer than P75 for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 3, 2010
CompletedFirst Posted
Study publicly available on registry
August 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMarch 17, 2015
March 1, 2015
4.8 years
August 3, 2010
March 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Time to first of composite cardiovascular events, MI or coronary artery revascularization and ischemic stroke
2.8 to 4 years
Study Arms (2)
Clopidogrel
ACTIVE COMPARATORPlavix® 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014
Triflusal
EXPERIMENTALDisgre® 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014
Interventions
Dose: 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014
Dose: 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014
Eligibility Criteria
You may qualify if:
- Patients who have non-cardiogenic ischemic stroke of TOAST classification within 30 days prior to screening
- ≥ 20 years of age; adult, at the date of signing the informed consent
- Written informed consent
You may not qualify if:
- History for bleeding tendency or recent major bleeding within 2 weeks
- Chronic liver disease (ALT \> 100 IU/L or AST \> 100 IU/L) or renal dysfunction (creatinine \> 4.0 mg/dl)
- Thrombocytopenia (platelet \< 100,000mm3)
- Any contraindication of antiplatelet agent
- Severe congestive heart failure
- Patients who need to take anticoagulants or two or more antiplatelet agents
- Severe concomitant disease with the expected survival less than 2 years
- Pregnant or nursing
- Any drug clinical trials within 30 days of signing the informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gangnam Severance Hospitallead
- Myung In Pharmaceutical Companycollaborator
- Yonsei Universitycollaborator
Study Sites (18)
Department of Neurology, Wonju Christian Hospital, Yonei University Wonju College of Medicine
Wŏnju, Gangwon-do, 220-701, South Korea
Department of Neurology, National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do, 410-719, South Korea
Department of Neurology, CHA Bundang Medical Center, CHA University School of Medicine
Seongnam-si, Gyeonggi-do, 463-712, South Korea
Changwon Fatima Hospital
Changwon, Gyeongsangnam-do, 641-560, South Korea
Keimyung University Dongsan Medical Center
Daegu, 700-712, South Korea
Kyungpook National University Hospital
Daegu, 700-721, South Korea
Yeungnam University Hospital
Daegu, 705-717, South Korea
Department of Neurology, Konyang University Hospital
Daejeon, 302-718, South Korea
Department of Neurology, Chosun University Hospital
Gwangju, 501-717, South Korea
Department of Neurology, National Medical Center
Seoul, 100-799, South Korea
Department of Neurology, Severance Hospital, Yonsei University College of Medicine
Seoul, 120-752, South Korea
KyungHee University Medical Center
Seoul, 130-702, South Korea
Department of Neurology, Kyung Hee University Hospital at Gangdong
Seoul, 134-727, South Korea
Department of Neurology, Gangnam Severance Hospital, Yonsei Univ. College of Medicine
Seoul, 135-720, South Korea
Korea University Anam Hospital
Seoul, 136-705, South Korea
Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine
Seoul, 139-707, South Korea
Department of Neurology, Korea University Guro Hospital
Seoul, 152-703, South Korea
Department of Neurology, Ewha Womans University Mokdong Hospital
Seoul, 158-710, South Korea
Related Publications (1)
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.
PMID: 26763917DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
KyungYul Lee, MD, PhD
Gangnam Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 3, 2010
First Posted
August 4, 2010
Study Start
March 1, 2010
Primary Completion
December 1, 2014
Study Completion
March 1, 2015
Last Updated
March 17, 2015
Record last verified: 2015-03