The Bleeding With Antithrombotic Therapy Study 2 (BAT2)

November 7, 2023 updated by: Kazunori Toyoda, National Cerebral and Cardiovascular Center, Japan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5306

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
        • National Hospital Organization Kyushu Medical Center
      • Kawasaki, Japan
        • St. Marianna University
      • Kobe, Japan
        • Kobe City Medical Center General Hospital
      • Nagoya, Japan
        • National Hospital Organization Nagoya Medical Center
      • Saga, Japan
        • Saga University
      • Tokushima, Japan
        • Tokushima University
      • Tokyo, Japan
        • Juntendo University
      • Tokyo, Japan
        • Kyorin University
    • Osaka
      • Suita, Osaka, Japan, 5658565
        • National Cerebral and Cardiovascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ISTH major bleeding
Time Frame: within 2 years
within 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinically relevant non-major bleeding
Time Frame: within 2 years
within 2 years
Hemorrhagic event details
Time Frame: within 2 years
within 2 years
Ischemic events and those details
Time Frame: within 2 years
within 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cerebral and Cardiovascular Center, Japan

Collaborators

Japan Agency for Medical Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (Estimated)

September 5, 2016

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16ek0210055h
  • 000023669 (Other Identifier: UMIN Clinical Trials Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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