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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01581502
Acronym
SAMURAI-NVAF
Enrollment
1000
Registered
2012-04-20
Start date
2011-09-30
Completion date
2016-12-31
Last updated
2015-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Stroke, Acute

Keywords

Anticoagulation, Recurrent stroke, Bleeding

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.

Interventions

This is an observational, not intervention, study.

Sponsors

Ministry of Health, Labour and Welfare, Japan
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ischemic events2 yearsRecurrence 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 bleeding2 yearsMajor bleeding according to the ISTH definition, including fatal bleeding, intracranial hemorrhage, etc

Secondary

MeasureTime frameDescription
modified Rankin Scale2 yearsmodified Rankin Scale
Modification of anticoagulant medication2 years

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026