Overview

This trial is active, not recruiting.

Conditions stroke, acute, atrial fibrillation
Treatment this is an observational study.
Sponsor Ministry of Health, Labour and Welfare, Japan
Start date September 2011
End date March 2016
Trial size 1000 participants
Trial identifier NCT01581502, samurai nvaf 2011, samurai2011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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
this is an observational study.
This is an observational, not intervention, study.

Primary Outcomes

Measure
Ischemic events
time frame: 2 years
major bleeding
time frame: 2 years

Secondary Outcomes

Measure
modified Rankin Scale
time frame: 2 years
Modification of anticoagulant medication
time frame: 2 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Stroke Acute Management With Urgent Risk-factor Assessment and Improvement (SAMURAI) Study on Anticoagulant Therapy in Nonvalvular Atrial Fibrillation (NVAF)
Principal investigator Kazunori Toyoda, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Ministry of Health, Labour and Welfare, Japan.