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

Primary Purpose

Cerebral Infarction

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Triflusal
Clopidogrel
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Infarction focused on measuring prospective, randomized, open label, multi-center, double-blind for CYP2C19 genotypes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurology, Wonju Christian Hospital, Yonei University Wonju College of Medicine
  • Department of Neurology, National Health Insurance Corporation Ilsan Hospital
  • Department of Neurology, CHA Bundang Medical Center, CHA University School of Medicine
  • Changwon Fatima Hospital
  • Keimyung University Dongsan Medical Center
  • Kyungpook National University Hospital
  • Yeungnam University Hospital
  • Department of Neurology, Konyang University Hospital
  • Department of Neurology, Chosun University Hospital
  • Department of Neurology, National Medical Center
  • Department of Neurology, Severance Hospital, Yonsei University College of Medicine
  • KyungHee University Medical Center
  • Department of Neurology, Kyung Hee University Hospital at Gangdong
  • Department of Neurology, Gangnam Severance Hospital, Yonsei Univ. College of Medicine
  • Korea University Anam Hospital
  • Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine
  • Department of Neurology, Korea University Guro Hospital
  • Department of Neurology, Ewha Womans University Mokdong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clopidogrel

Triflusal

Arm Description

Plavix® 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014

Disgre® 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
August 3, 2010
Last Updated
March 16, 2015
Sponsor
Gangnam Severance Hospital
Collaborators
Myung In Pharmaceutical Company, Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01174693
Brief Title
Comparison of Triflusal and Clopidogrel in Secondary Prevention of Stroke Based on the Genotyping
Acronym
MAESTRO
Official Title
Comparison of Triflusal and Clopidogrel Effect in Secondary Prevention of Stroke Based on the Cytochrome P450 2C19 Genotyping
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
Collaborators
Myung In Pharmaceutical Company, Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
Keywords
prospective, randomized, open label, multi-center, double-blind for CYP2C19 genotypes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
795 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Plavix® 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014
Arm Title
Triflusal
Arm Type
Experimental
Arm Description
Disgre® 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014
Intervention Type
Drug
Intervention Name(s)
Triflusal
Other Intervention Name(s)
Disgren®
Intervention Description
Dose: 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix®
Intervention Description
Dose: 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014
Primary Outcome Measure Information:
Title
Time to first recurrent stroke
Description
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).
Time Frame
2.8 to 4 years
Secondary Outcome Measure Information:
Title
Time to first of composite cardiovascular events, MI or coronary artery revascularization and ischemic stroke
Description
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).
Time Frame
2.8 to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KyungYul Lee, MD, PhD
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Wonju Christian Hospital, Yonei University Wonju College of Medicine
City
Wonju-si
State/Province
Gangwon-do
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Department of Neurology, National Health Insurance Corporation Ilsan Hospital
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-719
Country
Korea, Republic of
Facility Name
Department of Neurology, CHA Bundang Medical Center, CHA University School of Medicine
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-712
Country
Korea, Republic of
Facility Name
Changwon Fatima Hospital
City
Changwon
State/Province
Gyeongsangnam-do
ZIP/Postal Code
641-560
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Department of Neurology, Konyang University Hospital
City
Daejeon
ZIP/Postal Code
302-718
Country
Korea, Republic of
Facility Name
Department of Neurology, Chosun University Hospital
City
Gwangju
ZIP/Postal Code
501-717
Country
Korea, Republic of
Facility Name
Department of Neurology, National Medical Center
City
Seoul
ZIP/Postal Code
100-799
Country
Korea, Republic of
Facility Name
Department of Neurology, Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
KyungHee University Medical Center
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Department of Neurology, Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of
Facility Name
Department of Neurology, Gangnam Severance Hospital, Yonsei Univ. College of Medicine
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine
City
Seoul
ZIP/Postal Code
139-707
Country
Korea, Republic of
Facility Name
Department of Neurology, Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Department of Neurology, Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26763917
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.
Results Reference
derived

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

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