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

NCT ID: NCT01581502

Last Updated: 2015-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke, Acute Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

This is an observational study.

Intervention Type OTHER

This is an observational, not intervention, study.

Interventions

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This is an observational study.

This is an observational, not intervention, study.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kazunori Toyoda

National Cerebral and Cardiovascular Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kazunori Toyoda, MD

Role: PRINCIPAL_INVESTIGATOR

SAMURAI Study Investigators

Locations

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National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Site Status

Toyota Memorial Hospital

Toyota, Aichi-ken, Japan

Site Status

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, Japan

Site Status

Brain Attack Center Ota Memorial Hospital

Fukuyama, Hiroshima, Japan

Site Status

Nakamura Memorial Hospital

Sapporo, Hokkaido, Japan

Site Status

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Site Status

National Hospital Organization Kagoshima Medical Center

Kagoshima, Kagoshima-ken, Japan

Site Status

St Marianna University School of Medicine

Kawasaki, Kanagawa, Japan

Site Status

Japanese Red Cross Kumamoto Hospital

Kumamoto, Kumamoto, Japan

Site Status

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Kyoto, Japan

Site Status

South Miyagi Medical Center

Ōkawara, Miyagi, Japan

Site Status

Kohnan Hospital

Sendai, Miyagi, Japan

Site Status

Kawasaki Medical School

Kurashiki, Okayama-ken, Japan

Site Status

National Cerebral and Cardiovascular Center

Suita, Osaka, Japan

Site Status

Jichi Medical University School of Medicine

Shimotsuke, Tochigi, Japan

Site Status

Kyorin University School of Medicine

Mitaka, Tokyo, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type RESULT
PMID: 25581108 (View on PubMed)

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.

Reference Type RESULT
PMID: 25744752 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35253443 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34743551 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32098607 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31964290 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30691339 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27531346 (View on PubMed)

Other Identifiers

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samurai nvaf 2011

Identifier Type: REGISTRY

Identifier Source: secondary_id

samurai2011

Identifier Type: -

Identifier Source: org_study_id

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