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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Kazunori Toyoda, Ministry of Health, Labour and Welfare, Japan.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581502
First Posted: April 20, 2012
Last Update Posted: September 2, 2015
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.
Information provided by (Responsible Party):
Kazunori Toyoda, Ministry of Health, Labour and Welfare, Japan
  Purpose
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 Kazunori Toyoda, Ministry of Health, Labour and Welfare, Japan:

Primary Outcome Measures:
  • 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)

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


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

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

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.

  Eligibility

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, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
inpatients
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01581502


Locations
Japan
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
Investigators
Principal Investigator: Kazunori Toyoda, MD SAMURAI Study Investigators
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kazunori Toyoda, National Cerebral and Cardiovascular Center, Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov Identifier: NCT01581502     History of Changes
Other Study ID Numbers: samurai2011
samurai nvaf 2011 ( Registry Identifier: SAMURAI study investigators )
First Submitted: April 16, 2012
First Posted: April 20, 2012
Last Update Posted: September 2, 2015
Last Verified: August 2015

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

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