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Stroke, AcuteSAMURAI-NVAFNCT01581502

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

An observational study of Stroke, Acute and Atrial Fibrillation, run by Ministry of Health, Labour and Welfare, Japan at 16 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Stroke, Acute, Atrial Fibrillation
What is being tested?
This is an observational study.
How many people
1,000 participants
Where
16 sitesJapan
Study dates
Sep 2011to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: inpatients

Who may be able to join

  • Consecutive acute ischemic stroke/TIA patients with NVAF

Who cannot join

  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Japan16 sites

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka

  • Brain Attack Center Ota Memorial Hospital

    Fukuyama, Hiroshima

  • National Hospital Organization Kagoshima Medical Center

    Kagoshima, Kagoshima-ken

  • St Marianna University School of Medicine

    Kawasaki, Kanagawa

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, Kumamoto

  • Kawasaki Medical School

    Kurashiki, Okayama-ken

  • Japanese Red Cross Kyoto Daini Hospital

    Kyoto, Kyoto

  • Kyorin University School of Medicine

    Mitaka, Tokyo

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken

  • South Miyagi Medical Center

    Ōkawara, Miyagi

  • Nakamura Memorial Hospital

    Sapporo, Hokkaido

  • Kohnan Hospital

    Sendai, Miyagi

  • Jichi Medical University School of Medicine

    Shimotsuke, Tochigi

  • National Cerebral and Cardiovascular Center

    Suita, Osaka, 565-8565

  • Toyota Memorial Hospital

    Toyota, Aichi-ken

Other trials in Japan

About this study

Official title: 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.

Being tested
This is an observational study.
Keywords
Anticoagulation, Recurrent stroke, Bleeding
Medical subject headings
Stroke, Atrial Fibrillation, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • This is an observational study.Other

    This is an observational, not intervention, study.

Study groups in NCT01581502
Study groupRoleWhat they receive
NVAF, acute ischemic stroke/TIAConsecutive 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
Receives: Other: This is an observational study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 2 years

  2. major bleeding

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

    Measured: 2 years

Secondary outcomes (2)

  1. modified Rankin Scale

    modified Rankin Scale

    Measured: 2 years

  2. Modification of anticoagulant medication

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2012 (estimated)
  2. Study startSep 2011
  3. Primary completionMar 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01581502
Sponsor's protocol ID
samurai2011
Other IDs
samurai nvaf 2011
Acronym
SAMURAI-NVAF
Status last verified
Aug 2015
First submitted
16 Apr 2012
Last updated
2 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25581108

  • 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.

    PubMed 25744752

  • 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.

    PubMed 35253443

  • 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.

    PubMed 34743551

  • 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.

    PubMed 32098607

  • 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.

    PubMed 31964290

  • 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.

    PubMed 30691339

  • 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.

    PubMed 27531346

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, Acute and Atrial Fibrillation, run by Ministry of Health, Labour and Welfare, Japan at 16 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ischemic events (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01581502, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.

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