CoMparison of TriflusAl and Clopidogrel Effect in Secondary Prevention of STroke Based on the CytochRome P450 2C19 GenOtyping (MAESTRO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Myung In Pharmaceutical Company, Ltd.
Yonsei University
Information provided by (Responsible Party):
KyungYul Lee, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT01174693
First received: August 3, 2010
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Cerebral Infarction
Drug: Triflusal
Drug: Clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Triflusal and Clopidogrel Effect in Secondary Prevention of Stroke Based on the Cytochrome P450 2C19 Genotyping

Resource links provided by NLM:


Further study details as provided by Gangnam Severance Hospital:

Primary Outcome Measures:
  • Time to first recurrent stroke [ Time Frame: 2.8 to 4 years ] [ Designated as safety issue: No ]

    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 [ Time Frame: 2.8 to 4 years ] [ Designated as safety issue: No ]

    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).



Enrollment: 795
Study Start Date: March 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Disgren®

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174693

Locations
Korea, Republic of
Department of Neurology, Wonju Christian Hospital, Yonei University Wonju College of Medicine
Wonju-si, Gangwon-do, Korea, Republic of, 220-701
Department of Neurology, National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-719
Department of Neurology, CHA Bundang Medical Center, CHA University School of Medicine
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Changwon Fatima Hospital
Changwon, Gyeongsangnam-do, Korea, Republic of, 641-560
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 700-712
Yeungnam University Hospital
Daegu, Korea, Republic of, 705-717
Department of Neurology, Konyang University Hospital
Daejeon, Korea, Republic of, 302-718
Department of Neurology, Chosun University Hospital
Gwangju, Korea, Republic of, 501-717
KyungHee University Medical Center
Seoul, Korea, Republic of, 130-702
Department of Neurology, Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
Department of Neurology, National Medical Center
Seoul, Korea, Republic of, 100-799
Department of Neurology, Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Department of Neurology, Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of, 158-710
Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine
Seoul, Korea, Republic of, 139-707
Department of Neurology, Gangnam Severance Hospital, Yonsei Univ. College of Medicine
Seoul, Korea, Republic of, 135-720
Department of Neurology, Kyung Hee University Hospital at Gangdong
Seoul, Korea, Republic of, 134-727
Sponsors and Collaborators
Gangnam Severance Hospital
Myung In Pharmaceutical Company, Ltd.
Yonsei University
Investigators
Principal Investigator: KyungYul Lee, MD, PhD Gangnam Severance Hospital
  More Information

No publications provided

Responsible Party: KyungYul Lee, MD, PhD, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT01174693     History of Changes
Other Study ID Numbers: MAESTRO-001
Study First Received: August 3, 2010
Last Updated: January 24, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Gangnam Severance Hospital:
prospective
randomized
open label
multi-center
double-blind for CYP2C19 genotypes

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Clopidogrel
Triflusal
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014