NCT02889653

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,306

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

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

First Submitted

Initial submission to the registry

August 30, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

3.4 years

First QC Date

August 30, 2016

Last Update Submit

November 7, 2023

Conditions

Cerebrovascular and Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • ISTH major bleeding

    within 2 years

Secondary Outcomes (3)

  • Clinically relevant non-major bleeding

    within 2 years

  • Hemorrhagic event details

    within 2 years

  • Ischemic events and those details

    within 2 years

Interventions

Any oral antithrombotics (antiplatelets or anticoagulants)DRUG

Eligibility Criteria

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

Patients with cerebrovascular or cardiovascular diseases who start or continue taking oral antithrombotics (antiplatelets and/or anticoagulants) to prevent vascular events in participating centers

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

National Cerebral and Cardiovascular Center

Suita, Osaka, 5658565, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan

Location

St. Marianna University

Kawasaki, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Japan

Location

National Hospital Organization Nagoya Medical Center

Nagoya, Japan

Location

Saga University

Saga, Japan

Location

Tokushima University

Tokushima, Japan

Location

Juntendo University

Tokyo, Japan

Location

Kyorin University

Tokyo, Japan

Location

Related Publications (4)

  • 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: 27531346RESULT

  • 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.

    PMID: 33598561RESULT

  • 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: 35253443RESULT

  • 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.

    PMID: 40534562DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Anticoagulants

Intervention Hierarchy (Ancestors)

Hematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and Chair, Department of Stroke and Cerebrovascular Diseases

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 5, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2020

Study Completion

March 1, 2021

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations

JP(9)