The Bleeding With Antithrombotic Therapy Study 2

NCT ID: NCT02889653

Last Updated: 2023-11-09

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

COMPLETED

Total Enrollment

5306 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2021-03-31

Brief Summary

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The purpose of this study is to determine the incidence and severity of bleeding complications in patients with cerebrovascular and cardiovascular diseases treated with oral antithrombotic therapy.

Detailed Description

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Conditions

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Cerebrovascular and Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Any oral antithrombotics (antiplatelets or anticoagulants)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with cerebrovascular or cardiovascular diseases who start or continue taking oral antithrombotics (antiplatelets and/or anticoagulants) to prevent vascular events
* Patients who are able to receive MRI
* Provision of written informed consent either directly or by a suitable surrogate

Exclusion Criteria

* MRI contraindication
* Any condition that in the opinion of the responsible physician or investigator that renders the patient unsuitable for the study
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Japan Agency for Medical Research and Development

OTHER_GOV

Sponsor Role collaborator

National Cerebral and Cardiovascular Center, Japan

OTHER

Sponsor Role lead

Responsible Party

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Kazunori Toyoda

Director and Chair, Department of Stroke and Cerebrovascular Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cerebral and Cardiovascular Center

Suita, Osaka, Japan

Site Status

National Hospital Organization Kyushu Medical Center

Fukuoka, , Japan

Site Status

St. Marianna University

Kawasaki, , Japan

Site Status

Kobe City Medical Center General Hospital

Kobe, , Japan

Site Status

National Hospital Organization Nagoya Medical Center

Nagoya, , Japan

Site Status

Saga University

Saga, , Japan

Site Status

Tokushima University

Tokushima, , Japan

Site Status

Juntendo University

Tokyo, , Japan

Site Status

Kyorin University

Tokyo, , Japan

Site Status

Countries

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Japan

References

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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 RESULT
PMID: 27531346 (View on PubMed)

Takagi M, Tanaka K, Miwa K, Sasaki M, Koga M, Hirano T, Kamiyama K, Yagita Y, Nagakane Y, Hoshino H, Terasaki T, Yakushiji Y, Kudo K, Ihara M, Yoshimura S, Yamaguchi Y, Shiozawa M, Toyoda K; for BAT2 Investigators. The bleeding with antithrombotic therapy study 2: Rationale, design, and baseline characteristics of the participants. Eur Stroke J. 2020 Dec;5(4):423-431. doi: 10.1177/2396987320960618. Epub 2020 Sep 24.

Reference Type RESULT
PMID: 33598561 (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 RESULT
PMID: 35253443 (View on PubMed)

Miwa K, Tanaka K, Koga M, Tanaka K, Yakushiji Y, Sasaki M, Kudo K, Shiozawa M, Yoshimura S, Ihara M, Fujimoto S, Hoshino H, Kamiyama K, Kawano H, Nagasawa H, Nagakane Y, Nishiyama K, Yagita Y, Yoshimura S, Hirano T, Toyoda K; BAT2 Investigators. Prediction Model to Optimize Long-Term Antithrombotic Therapy Using Covert Vascular Brain Injury and Clinical Features. Stroke. 2025 Sep;56(9):2605-2616. doi: 10.1161/STROKEAHA.125.050859. Epub 2025 Jun 19.

Reference Type DERIVED
PMID: 40534562 (View on PubMed)

Other Identifiers

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000023669

Identifier Type: OTHER

Identifier Source: secondary_id

16ek0210055h

Identifier Type: -

Identifier Source: org_study_id

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