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

Ministry of Health, Labour and Welfare, Japan1,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Stroke, Acute Atrial Fibrillation

Interventions

This is an observational study.OTHER

This is an observational, not intervention, study.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (16)

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Toyota Memorial Hospital

Toyota, Aichi-ken, Japan

Outcomes

Primary Outcomes

Ischemic events

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)

Time frame: 2 years

major bleeding

Major bleeding according to the ISTH definition, including fatal bleeding, intracranial hemorrhage, etc

Time frame: 2 years

Secondary Outcomes

modified Rankin Scale

Time frame: 2 years

Modification of anticoagulant medication

Time frame: 2 years

Data from ClinicalTrials.gov

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