Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-10 @ 8:31 PM
Study NCT ID:
NCT01581502
Status:
UNKNOWN
Last Update Posted:
2015-09-02
First Post:
2012-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2012-04-16', 'studyFirstSubmitQcDate': '2012-04-18', 'lastUpdatePostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ischemic events', 'timeFrame': '2 years', 'description': 'Recurrence of ischemic stroke/TIA, ACS, systemic embolism, aortic dissection, rupture of aortic aneurysm, peripheral artery disease (required hospitalization), VTE, revascularization (including CEA/CAS, PCI, etc)'}, {'measure': 'major bleeding', 'timeFrame': '2 years', 'description': 'Major bleeding according to the ISTH definition, including fatal bleeding, intracranial hemorrhage, etc'}], 'secondaryOutcomes': [{'measure': 'modified Rankin Scale', 'timeFrame': '2 years', 'description': 'modified Rankin Scale'}, {'measure': 'Modification of anticoagulant medication', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anticoagulation', 'Recurrent stroke', 'Bleeding'], 'conditions': ['Stroke, Acute', 'Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '25581108', 'type': 'RESULT', 'citation': 'Toyoda K, Arihiro S, Todo K, Yamagami H, Kimura K, Furui E, Terasaki T, Shiokawa Y, Kamiyama K, Takizawa S, Okuda S, Okada Y, Kameda T, Nagakane Y, Hasegawa Y, Mochizuki H, Ito Y, Nakashima T, Takamatsu K, Nishiyama K, Kario K, Sato S, Koga M; SAMURAI Study Investigators. Trends in oral anticoagulant choice for acute stroke patients with nonvalvular atrial fibrillation in Japan: the SAMURAI-NVAF study. Int J Stroke. 2015 Aug;10(6):836-42. doi: 10.1111/ijs.12452. Epub 2015 Jan 12.'}, {'pmid': '25744752', 'type': 'RESULT', 'citation': 'Toyoda K. Is anticoagulant therapy unnecessary for lower-risk Japanese patients with atrial fibrillation? Lessons from the SAMURAI-NVAF and BAT studies. Circ J. 2015;79(2):307-9. doi: 10.1253/circj.CJ-14-1350. Epub 2014 Dec 24. No abstract available.'}, {'pmid': '35253443', 'type': 'DERIVED', 'citation': 'Tanaka K, Miwa K, Takagi M, Sasaki M, Yakushiji Y, Kudo K, Shiozawa M, Tanaka J, Nishihara M, Yamaguchi Y, Fujita K, Honda Y, Kawano H, Ide T, Yoshimura S, Koga M, Hirano T, Toyoda K. Increased Cerebral Small Vessel Disease Burden With Renal Dysfunction and Albuminuria in Patients Taking Antithrombotic Agents: The Bleeding With Antithrombotic Therapy 2. J Am Heart Assoc. 2022 Mar 15;11(6):e024749. doi: 10.1161/JAHA.121.024749. Epub 2022 Mar 5.'}, {'pmid': '34743551', 'type': 'DERIVED', 'citation': 'Tanaka K, Koga M, Lee KJ, Kim BJ, Mizoguchi T, Park EL, Lee J, Yoshimura S, Cha JK, Lee BC, Koge J, Bae HJ, Toyoda K; CRCS-K Investigators, the SAMURAI Study Investigators. Transesophageal Echocardiography in Ischemic Stroke With Atrial Fibrillation. J Am Heart Assoc. 2021 Nov 16;10(22):e022242. doi: 10.1161/JAHA.121.022242. Epub 2021 Nov 6.'}, {'pmid': '32098607', 'type': 'DERIVED', 'citation': 'Tanaka K, Koga M, Lee KJ, Kim BJ, Park EL, Lee J, Mizoguchi T, Yoshimura S, Cha JK, Lee BC, Nakahara J, Suzuki N, Bae HJ, Toyoda K; CRCS-K Investigators and the SAMURAI Study Investigators. Atrial Fibrillation-Associated Ischemic Stroke Patients With Prior Anticoagulation Have Higher Risk for Recurrent Stroke. Stroke. 2020 Apr;51(4):1150-1157. doi: 10.1161/STROKEAHA.119.027275. Epub 2020 Feb 26.'}, {'pmid': '31964290', 'type': 'DERIVED', 'citation': 'Mizoguchi T, Tanaka K, Toyoda K, Yoshimura S, Itabashi R, Takagi M, Todo K, Shiozawa M, Yagita Y, Yoshimoto T, Terasaki T, Yamagami H, Takizawa S, Inoue M, Kamiyama K, Ihara M, Okada Y, Kitazono T, Koga M; SAMURAI Study Investigators. Early Initiation of Direct Oral Anticoagulants After Onset of Stroke and Short- and Long-Term Outcomes of Patients With Nonvalvular Atrial Fibrillation. Stroke. 2020 Mar;51(3):883-891. doi: 10.1161/STROKEAHA.119.028118. Epub 2020 Jan 22.'}, {'pmid': '30691339', 'type': 'DERIVED', 'citation': 'Tokunaga K, Koga M, Itabashi R, Yamagami H, Todo K, Yoshimura S, Kimura K, Sato S, Terasaki T, Inoue M, Shiokawa Y, Takagi M, Kamiyama K, Tanaka K, Takizawa S, Shiozawa M, Okuda S, Okada Y, Kameda T, Nagakane Y, Hasegawa Y, Shibuya S, Ito Y, Matsuoka H, Takamatsu K, Nishiyama K, Kario K, Yagita Y, Fujita K, Ando D, Kumamoto M, Arihiro S, Toyoda K; SAMURAI Study Investigators. Prior Anticoagulation and Short- or Long-Term Clinical Outcomes in Ischemic Stroke or Transient Ischemic Attack Patients With Nonvalvular Atrial Fibrillation. J Am Heart Assoc. 2019 Feb 5;8(3):e010593. doi: 10.1161/JAHA.118.010593.'}, {'pmid': '27531346', 'type': 'DERIVED', 'citation': 'Koga M, Yoshimura S, Hasegawa Y, Shibuya S, Ito Y, Matsuoka H, Takamatsu K, Nishiyama K, Todo K, Kimura K, Furui E, Terasaki T, Shiokawa Y, Kamiyama K, Takizawa S, Okuda S, Okada Y, Kameda T, Nagakane Y, Yagita Y, Kario K, Shiozawa M, Sato S, Yamagami H, Arihiro S, Toyoda K; SAMURAI Study Investigators. Higher Risk of Ischemic Events in Secondary Prevention for Patients With Persistent Than Those With Paroxysmal Atrial Fibrillation. Stroke. 2016 Oct;47(10):2582-8. doi: 10.1161/STROKEAHA.116.013746. Epub 2016 Aug 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine choice of anticoagulant therapy during acute and chronic stages of ischemic stroke/TIA and short- and long-term outcomes, including stroke recurrence and bleeding complications, in patients having nonvalvular atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'inpatients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Consecutive acute ischemic stroke/TIA patients with NVAF\n\nExclusion Criteria:\n\n1. Rheumatic mitral valve disease\n2. A history of prosthetic valve replacement or mitral valve surgical repair\n3. Active infective endocarditis\n4. Patient, family member or legally responsible person does not have given informed consent\n5. Inappropriate patient's conditions for study enrollment in the opinion of the investigator"}, 'identificationModule': {'nctId': 'NCT01581502', 'acronym': 'SAMURAI-NVAF', 'briefTitle': 'SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health, Labour and Welfare, Japan'}, 'officialTitle': 'Stroke Acute Management With Urgent Risk-factor Assessment and Improvement (SAMURAI) Study on Anticoagulant Therapy in Nonvalvular Atrial Fibrillation (NVAF)', 'orgStudyIdInfo': {'id': 'samurai2011'}, 'secondaryIdInfos': [{'id': 'samurai nvaf 2011', 'type': 'REGISTRY', 'domain': 'SAMURAI study investigators'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'NVAF, acute ischemic stroke/TIA', 'description': 'Consecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation; most of these patients begin to receive anticoagulant therapy after index stroke/TIA for secondary prevention', 'interventionNames': ['Other: This is an observational study.']}], 'interventions': [{'name': 'This is an observational study.', 'type': 'OTHER', 'description': 'This is an observational, not intervention, study.', 'armGroupLabels': ['NVAF, acute ischemic stroke/TIA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'National Hospital Organization Nagoya Medical Center', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Toyota', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Toyota Memorial Hospital', 'geoPoint': {'lat': 35.08333, 'lon': 137.15}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'National Hospital Organization Kyushu Medical Center', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuyama', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Brain Attack Center Ota Memorial Hospital', 'geoPoint': {'lat': 34.48333, 'lon': 133.36667}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Nakamura Memorial Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kobe City Medical Center General Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'National Hospital Organization Kagoshima Medical Center', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'St Marianna University School of Medicine', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Japanese Red Cross Kumamoto Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Japanese Red Cross Kyoto Daini Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Ōkawara', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'South Miyagi Medical Center', 'geoPoint': {'lat': 38.05, 'lon': 140.73361}}, {'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Kohnan Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Kawasaki Medical School', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'zip': '565-8565', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'National Cerebral and Cardiovascular Center', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Shimotsuke', 'state': 'Tochigi', 'country': 'Japan', 'facility': 'Jichi Medical University School of Medicine', 'geoPoint': {'lat': 36.41323, 'lon': 139.86622}}, {'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kyorin University School of Medicine', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}], 'overallOfficials': [{'name': 'Kazunori Toyoda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SAMURAI Study Investigators'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health, Labour and Welfare, Japan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'National Cerebral and Cardiovascular Center', 'investigatorFullName': 'Kazunori Toyoda', 'investigatorAffiliation': 'Ministry of Health, Labour and Welfare, Japan'}}}}