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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01581502
Recruitment Status : Unknown
Verified August 2015 by Kazunori Toyoda, Ministry of Health, Labour and Welfare, Japan.
Recruitment status was:  Active, not recruiting
First Posted : April 20, 2012
Last Update Posted : September 2, 2015
Information provided by (Responsible Party):
Kazunori Toyoda, Ministry of Health, Labour and Welfare, Japan

Brief Summary:
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 or disease Intervention/treatment
Stroke, Acute Atrial Fibrillation Other: This is an observational study.

Study Type : Observational
Estimated Enrollment : 1000 participants
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)
Study Start Date : September 2011
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Ischemic events [ Time Frame: 2 years ]
    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)

  2. major bleeding [ Time Frame: 2 years ]
    Major bleeding according to the ISTH definition, including fatal bleeding, intracranial hemorrhage, etc

Secondary Outcome Measures :
  1. modified Rankin Scale [ Time Frame: 2 years ]
    modified Rankin Scale

  2. Modification of anticoagulant medication [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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 ( Registry Identifier: SAMURAI study investigators )
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015

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

Additional relevant MeSH terms:
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes