Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A

External Links