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

Atrial Fibrillation Clinical Trial

— SAMURAI-NVAF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01581502
• Other study ID #: samurai2011
• Secondary ID: samurai nvaf 201
• Status: Active, not recruiting
• Phase: N/A
• First received: April 16, 2012
• Last updated: August 31, 2015
• Start date: September 2011
• Est. completion date: December 2016

Study information

• Verified date: August 2015
• Source: Ministry of Health, Labour and Welfare, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke
• Stroke, Acute

Intervention

Other:
• This is an observational study.
This is an observational, not intervention, study.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

References & Publications (2)

Toyoda K, Arihiro S, Todo K, Yamagami H, Kimura K, Furui E, Terasaki T, Shiokawa Y, Kamiyama K, Takizawa S, Okuda S, Okada Y, Kameda T, Nagakane Y, Hasegawa Y, Mochizuki H, Ito Y, Nakashima T, Takamatsu K, Nishiyama K, Kario K, Sato S, Koga M; SAMURAI Stu — View Citation

Toyoda K. Is anticoagulant therapy unnecessary for lower-risk Japanese patients with atrial fibrillation? Lessons from the SAMURAI-NVAF and BAT studies. Circ J. 2015;79(2):307-9. doi: 10.1253/circj.CJ-14-1350. Epub 2014 Dec 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 years	Yes
Primary	major bleeding	Major bleeding according to the ISTH definition, including fatal bleeding, intracranial hemorrhage, etc	2 years	Yes
Secondary	modified Rankin Scale	modified Rankin Scale	2 years	No
Secondary	Modification of anticoagulant medication		2 years	No

External Links

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