Cerebrovascular and Cardiovascular Diseases Clinical Trial
— BAT2Official title:
The Bleeding With Antithrombotic Therapy Study 2
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] |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
National Cerebral and Cardiovascular Center, Japan | Japan Agency for Medical Research and Development |
Japan,
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
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 |