Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-27 @ 3:14 AM
Study NCT ID:
NCT01174693
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2010-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Triflusal and Clopidogrel in Secondary Prevention of Stroke Based on the Genotyping
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002544', 'term': 'Cerebral Infarction'}], 'ancestors': [{'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C016167', 'term': 'triflusal'}, {'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 795}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-16', 'studyFirstSubmitDate': '2010-08-03', 'studyFirstSubmitQcDate': '2010-08-03', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first recurrent stroke', 'timeFrame': '2.8 to 4 years', '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.\n\nWe 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).'}], 'secondaryOutcomes': [{'measure': 'Time to first of composite cardiovascular events, MI or coronary artery revascularization and ischemic stroke', 'timeFrame': '2.8 to 4 years', '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.\n\nWe 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).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prospective', 'randomized', 'open label', 'multi-center', 'double-blind for CYP2C19 genotypes'], 'conditions': ['Cerebral Infarction']}, 'referencesModule': {'references': [{'pmid': '26763917', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who have non-cardiogenic ischemic stroke of TOAST classification within 30 days prior to screening\n2. ≥ 20 years of age; adult, at the date of signing the informed consent\n3. Written informed consent\n\nExclusion Criteria:\n\n1. History for bleeding tendency or recent major bleeding within 2 weeks\n2. Chronic liver disease (ALT \\> 100 IU/L or AST \\> 100 IU/L) or renal dysfunction (creatinine \\> 4.0 mg/dl)\n3. Thrombocytopenia (platelet \\< 100,000mm3)\n4. Any contraindication of antiplatelet agent\n5. Severe congestive heart failure\n6. Patients who need to take anticoagulants or two or more antiplatelet agents\n7. Severe concomitant disease with the expected survival less than 2 years\n8. Pregnant or nursing\n9. Any drug clinical trials within 30 days of signing the informed consent'}, 'identificationModule': {'nctId': 'NCT01174693', 'acronym': 'MAESTRO', 'briefTitle': 'Comparison of Triflusal and Clopidogrel in Secondary Prevention of Stroke Based on the Genotyping', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'Comparison of Triflusal and Clopidogrel Effect in Secondary Prevention of Stroke Based on the Cytochrome P450 2C19 Genotyping', 'orgStudyIdInfo': {'id': 'MAESTRO-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clopidogrel', 'description': 'Plavix® 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014', 'interventionNames': ['Drug: Clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': 'Triflusal', 'description': 'Disgre® 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014', 'interventionNames': ['Drug: Triflusal']}], 'interventions': [{'name': 'Triflusal', 'type': 'DRUG', 'otherNames': ['Disgren®'], 'description': 'Dose: 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014', 'armGroupLabels': ['Triflusal']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'otherNames': ['Plavix®'], 'description': 'Dose: 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014', 'armGroupLabels': ['Clopidogrel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220-701', 'city': 'Wŏnju', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Department of Neurology, Wonju Christian Hospital, Yonei University Wonju College of Medicine', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'zip': '410-719', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Department of Neurology, National Health Insurance Corporation Ilsan Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '463-712', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Department of Neurology, CHA Bundang Medical Center, CHA University School of Medicine', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '641-560', 'city': 'Changwon', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Changwon Fatima Hospital', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'zip': '700-712', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '700-721', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '705-717', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '302-718', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Department of Neurology, Konyang University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '501-717', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Department of Neurology, Chosun University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '100-799', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology, National Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology, Severance Hospital, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '130-702', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'KyungHee University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '134-727', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology, Kyung Hee University Hospital at Gangdong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-720', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology, Gangnam Severance Hospital, Yonsei Univ. College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '136-705', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '139-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '152-703', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology, Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '158-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Neurology, Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'KyungYul Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gangnam Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Myung In Pharmaceutical Company', 'class': 'UNKNOWN'}, {'name': 'Yonsei University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'KyungYul Lee', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}