UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006930 |
|---|---|
| Receipt number | R000008188 |
| Scientific Title | Stroke Acute Management with Urgent Risk-factor Assessment and Improvement (SAMURAI) study on anticoagulant therapy in nonvalvular atrial fibrillation (NVAF) |
| Date of disclosure of the study information | 2011/12/22 |
| Last modified on | 2020/12/15 11:01:49 |
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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
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
toyoda@hsp.ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008188
