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

August 31, 2015 updated by: Kazunori Toyoda, Ministry of Health, Labour and Welfare, Japan

Stroke Acute Management With Urgent Risk-factor Assessment and Improvement (SAMURAI) Study on Anticoagulant Therapy in Nonvalvular Atrial Fibrillation (NVAF)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
        • National Hospital Organization Kyushu Medical Center
      • Kagoshima, Japan
        • National Hospital Organization Kagoshima Medical Center
      • Kumamoto, Japan
        • Japanese Red Cross Kumamoto Hospital
      • Kyoto, Japan
        • Japanese Red Cross Kyoto Daini Hospital
    • Aichi
      • Nagoya, Aichi, Japan
        • National Hospital Organization Nagoya Medical Center
      • Toyota, Aichi, Japan
        • Toyota Memorial Hospital
    • Hiroshima
      • Fukuyama, Hiroshima, Japan
        • Brain Attack Center Ota Memorial Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Nakamura Memorial Hospital
    • Hyogo
      • Kobe, Hyogo, Japan
        • Kobe City Medical Center General Hospital
    • Kanagawa
      • Kawasaki, Kanagawa, Japan
        • St Marianna University School of Medicine
    • Miyagi
      • Ogawara, Miyagi, Japan
        • South Miyagi Medical Center
      • Sendai, Miyagi, Japan
        • Kohnan Hospital
    • Okayama
      • Kurashiki, Okayama, Japan
        • Kawasaki Medical School
    • Osaka
      • Suita, Osaka, Japan, 565-8565
        • National Cerebral and Cardiovascular Center
    • Tochigi
      • Shimotsuke, Tochigi, Japan
        • Jichi Medical University School of Medicine
    • Tokyo
      • Mitaka, Tokyo, Japan
        • Kyorin University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

inpatients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
major bleeding
Time Frame: 2 years
Major bleeding according to the ISTH definition, including fatal bleeding, intracranial hemorrhage, etc
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale
Time Frame: 2 years
modified Rankin Scale
2 years
Modification of anticoagulant medication
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Labour and Welfare, Japan

Investigators

  • Principal Investigator: Kazunori Toyoda, MD, SAMURAI Study Investigators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

April 16, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • samurai2011
  • samurai nvaf 2011 (Registry Identifier: SAMURAI study investigators)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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