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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02889653
Other study ID # 16ek0210055h
Secondary ID 000023669
Status Completed
Phase
First received
Last updated
Start date October 2016
Est. completion date March 2021

Study information

Verified date November 2023
Source National Cerebral and Cardiovascular Center, Japan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 5306
Est. completion date March 2021
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Any oral antithrombotics (antiplatelets or anticoagulants)


Locations

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

Sponsors (2)

Lead Sponsor Collaborator
National Cerebral and Cardiovascular Center, Japan Japan Agency for Medical Research and Development

Country where clinical trial is conducted

Japan, 

References & Publications (3)

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, — View Citation

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 — View Citation

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 a — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary ISTH major bleeding within 2 years
Secondary Clinically relevant non-major bleeding within 2 years
Secondary Hemorrhagic event details within 2 years
Secondary Ischemic events and those details within 2 years