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

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.

Full Title of Study: “Stroke Acute Management With Urgent Risk-factor Assessment and Improvement (SAMURAI) Study on Anticoagulant Therapy in Nonvalvular Atrial Fibrillation (NVAF)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2016

Interventions

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

Arms, Groups and Cohorts

  • NVAF, acute ischemic stroke/TIA
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Ischemic events
    • Time Frame: 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
    • Time Frame: 2 years
    • Major bleeding according to the ISTH definition, including fatal bleeding, intracranial hemorrhage, etc

Secondary Measures

  • modified Rankin Scale
    • Time Frame: 2 years
    • modified Rankin Scale
  • Modification of anticoagulant medication
    • Time Frame: 2 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ministry of Health, Labour and Welfare, Japan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kazunori Toyoda, National Cerebral and Cardiovascular Center – Ministry of Health, Labour and Welfare, Japan
  • Overall Official(s)
    • Kazunori Toyoda, MD, Principal Investigator, SAMURAI Study Investigators

Citations Reporting on Results

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 Study Investigators. Trends in oral anticoagulant choice for acute stroke patients with nonvalvular atrial fibrillation in Japan: the SAMURAI-NVAF study. Int J Stroke. 2015 Aug;10(6):836-42. doi: 10.1111/ijs.12452. Epub 2015 Jan 12.

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. No abstract available.

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