UMIN-CTR Clinical Trial

Basic information
Public title	Stroke Acute Management with Urgent Risk-factor Assessment and Improvement (SAMURAI) study on anticoagulant therapy in nonvalvular atrial fibrillation (NVAF)
Acronym	SAMURAI-NVAF Study
Scientific Title	Stroke Acute Management with Urgent Risk-factor Assessment and Improvement (SAMURAI) study on anticoagulant therapy in nonvalvular atrial fibrillation (NVAF)
Scientific Title:Acronym	SAMURAI-NVAF Study
Region	Japan

Condition
Condition	Ischemic stroke
Classification by specialty	Cardiology Neurology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine short- and long-term outcomes, including stroke recurrence and bleeding complications, of each anticoagulant therapy during acute and chronic stages of ischemic stroke/TIA patients having nonvalvular atrial fibrillation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Ischemic stroke recurrence, systemic embolism and major hemorrhage during acute hospitalization or within the initial 30 days 2.Ischemic stroke recurrence, systemic embolism and major hemorrhage within 2 years. Vital and functional outcomes assessed by the modified Rankin Scale within observation period/modified Rakin scale at 3 months, 1 year, and 2 years after stroke
Key secondary outcomes	1.Ischemic event(ischemic stroke recurrence, revacularization, systemic embolism, ACS/PCI, DVT/PTE) 2.Hemorrhagic event(major hemorrhage, severe GI bleeding, transfusion) 3.Withdrawal of the anticoagulant therapy

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Consecutive acute ischemic stroke/TIA patients with NVAF who begin to receive anticoagulant therapy within 7 days after stroke onset
Key exclusion criteria	1.Rheumatic mitral valve disease 2.A history of prosthetic valve replacement or mitral valve surgical repair 3.Active infective endocarditis 4.Patient, family member or legally responsible person does not have given informed consent 5.Inappropriate patient's conditions for study enrollment in the opinion of the investigator
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Kazunori Middle name Last name Toyoda
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Cerebrovascular Medicine
Zip code	564-8565
Address	6-1 Kishibe-shimmachi, Suita, Osaka 564-8565, Japan
TEL	06-6170-1070
Email	toyoda@ncvc.go.jp

Public contact
Name of contact person	1st name Kazunori Middle name Last name Toyoda
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Cerebrovascular Medicine
Zip code	564-8565
Address	6-1 Kishibe-shimmachi, Suita, Osaka 564-8565, Japan
TEL	06-6170-1070
Homepage URL	https://www.stroke-ncvc.jp/NVAF/login.php
Email	toyoda@hsp.ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization	Grants-In-Aid(H23-Junkanki-Ippan-10) from the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Cerebral and Cardiovascular Center
Address	6-1 Kishibe-shimmachi, Suita, Osaka 564-8565, Japan
Tel	06-6170-1070
Email	rec-office-ac@ncvc.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立循環器病研究センター（大阪府） 自治医科大学（栃木県） 中村記念病院（北海道） 広南病院（宮城県） 杏林大学（東京都） 聖マリアンナ医科大学（神奈川県） 国立病院機構名古屋医療センター（愛知県） 神戸市立医療センター中央病院（兵庫県） 川崎医科大学（岡山県） 国立病院機構九州医療センター（福岡県） みやぎ県南中核病院（宮城県） トヨタ記念病院（愛知県） 京都第二赤十字病院（京都府） 脳神経センター大田記念病院（広島県） 熊本赤十字病院（熊本県） 国立病院機構鹿児島医療センター（鹿児島県） 東海大学医学部附属病院（神奈川県） 北里大学（神奈川県）

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 22 Day

Related information
URL releasing protocol	http://samurai.stroke-ncvc.jp/
Publication of results	Published

Result
URL related to results and publications	http://samurai.stroke-ncvc.jp/
Number of participants that the trial has enrolled	1192
Results	PUBLICATIONS Trends in oral anticoagulant choice for acute stroke patients with nonvalvular atrial fibrillation in Japan: The SAMURAI-NVAF Study. Int J Stroke. 2015; 10: 836-842. Three-month risk-bene t pro le of anticoagulation after stroke with atrial brillation: The SAMURAI-NVAF study. Int J Stroke 2016; 11: 565-574. Two-Year Outcomes of Anticoagulation for Acute Ischemic Stroke With Nonvalvular Atrial Fibrillation-SAMURAI-NVAF Study. Circ J. 2018 Jun 25;82(7):1935-1942
Results date posted	2020 Year 12 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	DOAC users were younger and had lower National Institutes of Health Stroke Scale, CHADS2 and discharge modified Rankin Scale scores than warfarin users (p<0.0001 each). Incidences of stroke/systemic embolism (adjusted hazard ratio, 1.07; 95%CI, 0.66-1.72), all ischemic events (1.13; 0.72-1.75), and ischemic stroke/TIA (1.58; 0.95-2.62) were similar between groups. [Circ J. 2018 Jun 25;82(7):1935-1942]
Participant flow	NVAF patients within 7 days after onset of ischemic stroke/TIA were enrolled in 18 stroke centers. We enrolled 1116 patients, taking either warfarin (650 patients) or DOACs (466 patients) at acute hospital discharge. [Circ J. 2018 Jun 25;82(7):1935-1942]
Adverse events	Risks of intracranial hemorrhage (0.32; 0.09-0.97) and death (0.41; 0.26-0.63) were significantly lower for DOAC users. Infection was the leading cause of death, accounting for 40% of deaths among warfarin users. [Circ J. 2018 Jun 25;82(7):1935-1942]
Outcome measures	Outcome measures included ischemic and bleeding events and mortality in the 2-year follow-up period. [Circ J. 2018 Jun 25;82(7):1935-1942]
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 09 Month 21 Day
Date of IRB	2011 Year 09 Month 21 Day
Anticipated trial start date	2011 Year 09 Month 21 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 05 Month 31 Day
Date trial data considered complete	2016 Year 06 Month 30 Day
Date analysis concluded	2016 Year 09 Month 30 Day

Other
Other related information	A prospective, multicenter, observational study

Management information
Registered date	2011 Year 12 Month 21 Day
Last modified on	2020 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008188