Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01174693
Recruitment Status : Completed
First Posted : August 4, 2010
Last Update Posted : March 17, 2015
Sponsor:
Collaborators:
Myung In Pharmaceutical Company
Yonsei University
Information provided by (Responsible Party):
KyungYul Lee, Gangnam Severance Hospital

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.

Condition or disease Intervention/treatment Phase
Cerebral Infarction Drug: Triflusal Drug: Clopidogrel Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 795 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


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 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®




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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).




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174693


Locations
Show Show 18 study locations
Sponsors and Collaborators
Gangnam Severance Hospital
Myung In Pharmaceutical Company
Yonsei University
Investigators
Layout table for investigator information
Principal Investigator: KyungYul Lee, MD, PhD Gangnam Severance Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: KyungYul Lee, MD, PhD, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT01174693    
Other Study ID Numbers: MAESTRO-001
First Posted: August 4, 2010    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Keywords provided by KyungYul Lee, Gangnam Severance Hospital:
prospective
randomized
open label
multi-center
double-blind for CYP2C19 genotypes
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Salicylates
Clopidogrel
Triflusal
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents