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

This study is currently recruiting participants.
Verified April 2012 by Ministry of Health, Labour and Welfare, Japan
Sponsor:
Information provided by (Responsible Party):
Kazunori Toyoda, Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov Identifier:
NCT01581502
First received: April 16, 2012
Last updated: April 18, 2012
Last verified: April 2012

April 16, 2012
April 18, 2012
September 2011
Not Provided
  • Ischemic events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Major bleeding according to the ISTH definition, including fatal bleeding, intracranial hemorrhage, etc
Same as current
Complete list of historical versions of study NCT01581502 on ClinicalTrials.gov Archive Site
  • modified Rankin Scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    modified Rankin Scale
  • Modification of anticoagulant medication [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

inpatients

  • Stroke, Acute
  • Atrial Fibrillation
Other: This is an observational study.
This is an observational, not intervention, study.
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
Intervention: Other: This is an observational study.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2015
Not Provided

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
Both
Not Provided
No
Contact: Shoji Arihiro, MD sarihiro@hsp.ncvc.go.jp
Japan
 
NCT01581502
samurai2011, samurai nvaf 2011
No
Kazunori Toyoda, Ministry of Health, Labour and Welfare, Japan
Ministry of Health, Labour and Welfare, Japan
Not Provided
Principal Investigator: Kazunori Toyoda, MD SAMURAI Study Investigators
Ministry of Health, Labour and Welfare, Japan
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP