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

March 16, 2015 updated by: KyungYul Lee, Gangnam Severance Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

795

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-712
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of, 700-721
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of, 705-717
        • Yeungnam University Hospital
      • Daejeon, Korea, Republic of, 302-718
        • Department of Neurology, Konyang University Hospital
      • Gwangju, Korea, Republic of, 501-717
        • Department of Neurology, Chosun University Hospital
      • Seoul, Korea, Republic of, 136-705
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 100-799
        • Department of Neurology, National Medical Center
      • Seoul, Korea, Republic of, 120-752
        • Department of Neurology, Severance Hospital, Yonsei University College of Medicine
      • Seoul, Korea, Republic of, 130-702
        • Kyunghee University Medical Center
      • Seoul, Korea, Republic of, 134-727
        • Department of Neurology, Kyung Hee University Hospital at Gangdong
      • Seoul, Korea, Republic of, 135-720
        • Department of Neurology, Gangnam Severance Hospital, Yonsei Univ. College of Medicine
      • Seoul, Korea, Republic of, 139-707
        • Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine
      • Seoul, Korea, Republic of, 152-703
        • Department of Neurology, Korea University Guro Hospital
      • Seoul, Korea, Republic of, 158-710
        • Department of Neurology, Ewha Womans University Mokdong Hospital
    • Gangwon-do
      • Wonju-si, Gangwon-do, Korea, Republic of, 220-701
        • Department of Neurology, Wonju Christian Hospital, Yonei University Wonju College of Medicine
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-719
        • Department of Neurology, National health insurance corporation ilsan Hospital
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
        • Department of Neurology, CHA Bundang Medical Center, CHA University School of Medicine
    • Gyeongsangnam-do
      • Changwon, Gyeongsangnam-do, Korea, Republic of, 641-560
        • Changwon Fatima Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clopidogrel
Plavix® 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014
Drug: Clopidogrel
Dose: 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014
Other Names:
  • Plavix®
Experimental: Triflusal
Disgre® 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014
Drug: Triflusal
Dose: 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014
Other Names:
  • Disgren®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first recurrent stroke
Time Frame: 2.8 to 4 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first of composite cardiovascular events, MI or coronary artery revascularization and ischemic stroke
Time Frame: 2.8 to 4 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Collaborators

Yonsei University
Myung In Pharmaceutical Company

Investigators

  • Principal Investigator: KyungYul Lee, MD, PhD, Gangnam Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 3, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (Estimate)

August 4, 2010

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 16, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAESTRO-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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