NCT01581502

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

16 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

4.5 years

First QC Date

April 16, 2012

Last Update Submit

August 31, 2015

Conditions

Stroke, AcuteAtrial Fibrillation

Keywords

AnticoagulationRecurrent strokeBleeding

Outcome Measures

Primary Outcomes (2)

  • 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

  • major bleeding

    Major bleeding according to the ISTH definition, including fatal bleeding, intracranial hemorrhage, etc

    2 years

Secondary Outcomes (2)

  • modified Rankin Scale

    2 years

  • Modification of anticoagulant medication

    2 years

Study Arms (1)

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

Other: This is an observational study.

Interventions

This is an observational study.OTHER

This is an observational, not intervention, study.

NVAF, acute ischemic stroke/TIA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

inpatients

You may qualify if:

  • Consecutive acute ischemic stroke/TIA patients with NVAF

You may not qualify if:

  • Rheumatic mitral valve disease
  • A history of prosthetic valve replacement or mitral valve surgical repair
  • Active infective endocarditis
  • Patient, family member or legally responsible person does not have given informed consent
  • Inappropriate patient's conditions for study enrollment in the opinion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Location

Toyota Memorial Hospital

Toyota, Aichi-ken, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, Japan

Location

Brain Attack Center Ota Memorial Hospital

Fukuyama, Hiroshima, Japan

Location

Nakamura Memorial Hospital

Sapporo, Hokkaido, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Location

National Hospital Organization Kagoshima Medical Center

Kagoshima, Kagoshima-ken, Japan

Location

St Marianna University School of Medicine

Kawasaki, Kanagawa, Japan

Location

Japanese Red Cross Kumamoto Hospital

Kumamoto, Kumamoto, Japan

Location

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Kyoto, Japan

Location

South Miyagi Medical Center

Ōkawara, Miyagi, Japan

Location

Kohnan Hospital

Sendai, Miyagi, Japan

Location

Kawasaki Medical School

Kurashiki, Okayama-ken, Japan

Location

National Cerebral and Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Location

Jichi Medical University School of Medicine

Shimotsuke, Tochigi, Japan

Location

Kyorin University School of Medicine

Mitaka, Tokyo, Japan

Location

Related Publications (8)

  • 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.

    PMID: 25581108RESULT

  • 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.

    PMID: 25744752RESULT

  • Tanaka K, Miwa K, Takagi M, Sasaki M, Yakushiji Y, Kudo K, Shiozawa M, Tanaka J, Nishihara M, Yamaguchi Y, Fujita K, Honda Y, Kawano H, Ide T, Yoshimura S, Koga M, Hirano T, Toyoda K. Increased Cerebral Small Vessel Disease Burden With Renal Dysfunction and Albuminuria in Patients Taking Antithrombotic Agents: The Bleeding With Antithrombotic Therapy 2. J Am Heart Assoc. 2022 Mar 15;11(6):e024749. doi: 10.1161/JAHA.121.024749. Epub 2022 Mar 5.

    PMID: 35253443DERIVED

  • Tanaka K, Koga M, Lee KJ, Kim BJ, Mizoguchi T, Park EL, Lee J, Yoshimura S, Cha JK, Lee BC, Koge J, Bae HJ, Toyoda K; CRCS-K Investigators, the SAMURAI Study Investigators. Transesophageal Echocardiography in Ischemic Stroke With Atrial Fibrillation. J Am Heart Assoc. 2021 Nov 16;10(22):e022242. doi: 10.1161/JAHA.121.022242. Epub 2021 Nov 6.

    PMID: 34743551DERIVED

  • Tanaka K, Koga M, Lee KJ, Kim BJ, Park EL, Lee J, Mizoguchi T, Yoshimura S, Cha JK, Lee BC, Nakahara J, Suzuki N, Bae HJ, Toyoda K; CRCS-K Investigators and the SAMURAI Study Investigators. Atrial Fibrillation-Associated Ischemic Stroke Patients With Prior Anticoagulation Have Higher Risk for Recurrent Stroke. Stroke. 2020 Apr;51(4):1150-1157. doi: 10.1161/STROKEAHA.119.027275. Epub 2020 Feb 26.

    PMID: 32098607DERIVED

  • Mizoguchi T, Tanaka K, Toyoda K, Yoshimura S, Itabashi R, Takagi M, Todo K, Shiozawa M, Yagita Y, Yoshimoto T, Terasaki T, Yamagami H, Takizawa S, Inoue M, Kamiyama K, Ihara M, Okada Y, Kitazono T, Koga M; SAMURAI Study Investigators. Early Initiation of Direct Oral Anticoagulants After Onset of Stroke and Short- and Long-Term Outcomes of Patients With Nonvalvular Atrial Fibrillation. Stroke. 2020 Mar;51(3):883-891. doi: 10.1161/STROKEAHA.119.028118. Epub 2020 Jan 22.

    PMID: 31964290DERIVED

  • Tokunaga K, Koga M, Itabashi R, Yamagami H, Todo K, Yoshimura S, Kimura K, Sato S, Terasaki T, Inoue M, Shiokawa Y, Takagi M, Kamiyama K, Tanaka K, Takizawa S, Shiozawa M, Okuda S, Okada Y, Kameda T, Nagakane Y, Hasegawa Y, Shibuya S, Ito Y, Matsuoka H, Takamatsu K, Nishiyama K, Kario K, Yagita Y, Fujita K, Ando D, Kumamoto M, Arihiro S, Toyoda K; SAMURAI Study Investigators. Prior Anticoagulation and Short- or Long-Term Clinical Outcomes in Ischemic Stroke or Transient Ischemic Attack Patients With Nonvalvular Atrial Fibrillation. J Am Heart Assoc. 2019 Feb 5;8(3):e010593. doi: 10.1161/JAHA.118.010593.

    PMID: 30691339DERIVED

  • Koga M, Yoshimura S, Hasegawa Y, Shibuya S, Ito Y, Matsuoka H, Takamatsu K, Nishiyama K, Todo K, Kimura K, Furui E, Terasaki T, Shiokawa Y, Kamiyama K, Takizawa S, Okuda S, Okada Y, Kameda T, Nagakane Y, Yagita Y, Kario K, Shiozawa M, Sato S, Yamagami H, Arihiro S, Toyoda K; SAMURAI Study Investigators. Higher Risk of Ischemic Events in Secondary Prevention for Patients With Persistent Than Those With Paroxysmal Atrial Fibrillation. Stroke. 2016 Oct;47(10):2582-8. doi: 10.1161/STROKEAHA.116.013746. Epub 2016 Aug 16.

    PMID: 27531346DERIVED

MeSH Terms

Conditions

StrokeAtrial FibrillationHemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kazunori Toyoda, MD

    SAMURAI Study Investigators

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National Cerebral and Cardiovascular Center

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 20, 2012

Study Start

September 1, 2011

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

September 2, 2015

Record last verified: 2015-08

Locations

JP(16)