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Completed

NCT Number: NCT02889653

The Bleeding With Antithrombotic Therapy Study 2

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.

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Key information

Conditions

Cerebrovascular and Cardiovascular Diseases Cardiovascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cerebral and Cardiovascular Center, Suita, Osaka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Any oral antithrombotics (antiplatelets or anticoagulants)

Drug

Primary outcomes

  1. ISTH major bleeding

    Time frame: within 2 years

Secondary outcomes

  1. Clinically relevant non-major bleeding

    Time frame: within 2 years

  2. Hemorrhagic event details

    Time frame: within 2 years

  3. Ischemic events and those details

    Time frame: within 2 years

Sponsors and collaborators

Lead sponsor

National Cerebral and Cardiovascular Center, Japan

Other

Collaborators

  • Japan Agency for Medical Research and Development

Registry information

Acronym: BAT2

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Sep 5, 2016
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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