SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Kazunori Toyoda, Ministry of Health, Labour and Welfare, Japan Identifier:
First received: April 16, 2012
Last updated: August 31, 2015
Last verified: August 2015

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.

Condition Intervention
Stroke, Acute
Atrial Fibrillation
Other: This is an observational study.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Stroke Acute Management With Urgent Risk-factor Assessment and Improvement (SAMURAI) Study on Anticoagulant Therapy in Nonvalvular Atrial Fibrillation (NVAF)

Resource links provided by NLM:

Further study details as provided by Ministry of Health, Labour and Welfare, Japan:

Primary Outcome Measures:
  • Ischemic events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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)

  • major bleeding [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Major bleeding according to the ISTH definition, including fatal bleeding, intracranial hemorrhage, etc

Secondary Outcome Measures:
  • modified Rankin Scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    modified Rankin Scale

  • Modification of anticoagulant medication [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: September 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NVAF, acute ischemic stroke/TIA
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
Other: This is an observational study.
This is an observational, not intervention, study.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population



Inclusion Criteria:

  • Consecutive acute ischemic stroke/TIA patients with NVAF

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01581502

National Hospital Organization Nagoya Medical Center
Nagoya, Aichi, Japan
Toyota Memorial Hospital
Toyota, Aichi, Japan
Brain Attack Center Ota Memorial Hospital
Fukuyama, Hiroshima, Japan
Nakamura Memorial Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
Kobe, Hyogo, Japan
St Marianna University School of Medicine
Kawasaki, Kanagawa, Japan
South Miyagi Medical Center
Ogawara, Miyagi, Japan
Kohnan Hospital
Sendai, Miyagi, Japan
Kawasaki Medical School
Kurashiki, Okayama, Japan
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan, 565-8565
Jichi Medical University School of Medicine
Shimotsuke, Tochigi, Japan
Kyorin University School of Medicine
Mitaka, Tokyo, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan
National Hospital Organization Kagoshima Medical Center
Kagoshima, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Japan
Japanese Red Cross Kyoto Daini Hospital
Kyoto, Japan
Sponsors and Collaborators
Ministry of Health, Labour and Welfare, Japan
Principal Investigator: Kazunori Toyoda, MD SAMURAI Study Investigators
  More Information

Additional Information:
Responsible Party: Kazunori Toyoda, National Cerebral and Cardiovascular Center, Ministry of Health, Labour and Welfare, Japan Identifier: NCT01581502     History of Changes
Other Study ID Numbers: samurai2011, samurai nvaf 2011
Study First Received: April 16, 2012
Last Updated: August 31, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ministry of Health, Labour and Welfare, Japan:
Recurrent stroke

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Heart Diseases
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 06, 2015