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

• Conditions: Stroke, Acute; Atrial Fibrillation
• Interventions: Other: This is an observational study.

• Registration Number: NCT01581502
• Lead Sponsor: Ministry of Health, Labour and Welfare, Japan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-20
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-02
• Primary Completion: 2016-03
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NVAF, acute ischemic stroke/TIA	This is an observational study.	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

Primary Outcome Measures

Name	Time	Method
Ischemic events	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	2 years	Major bleeding according to the ISTH definition, including fatal bleeding, intracranial hemorrhage, etc

Secondary Outcome Measures

Name	Time	Method
modified Rankin Scale	2 years	modified Rankin Scale
Modification of anticoagulant medication	2 years

Trial Locations

Locations (16)

Brain Attack Center Ota Memorial Hospital; 🇯🇵 Fukuyama, Hiroshima, Japan

St Marianna University School of Medicine; 🇯🇵 Kawasaki, Kanagawa, Japan

Kobe City Medical Center General Hospital; 🇯🇵 Kobe, Hyogo, Japan

South Miyagi Medical Center; 🇯🇵 Ogawara, Miyagi, Japan

Kohnan Hospital; 🇯🇵 Sendai, Miyagi, Japan

Kyorin University School of Medicine; 🇯🇵 Mitaka, Tokyo, Japan

Jichi Medical University School of Medicine; 🇯🇵 Shimotsuke, Tochigi, 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

National Hospital Organization Nagoya Medical Center; 🇯🇵 Nagoya, Aichi, Japan

Toyota Memorial Hospital; 🇯🇵 Toyota, Aichi, Japan

Nakamura Memorial Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Kawasaki Medical School; 🇯🇵 Kurashiki, Okayama, Japan

National Cerebral and Cardiovascular Center; 🇯🇵 Suita, Osaka, Japan