Clinical trial NCT02889653: The Bleeding With Antithrombotic Therapy Study 2
Official title: The Bleeding With Antithrombotic Therapy Study 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular and Cardiovascular Diseases
Lead sponsor: National Cerebral and Cardiovascular Center, Japan
Sponsor class: OTHER
Collaborators: name: Japan Agency for Medical Research and Development
First posted: 2016-09-05
Enrollment: 5306
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: ISTH major bleeding
timeFrame: within 2 years
Secondary outcomes:
measure: Clinically relevant non-major bleeding
timeFrame: within 2 years
measure: Hemorrhagic event details
timeFrame: within 2 years
measure: Ischemic events and those details
timeFrame: within 2 years
Other outcomes:
Locations:
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Kawasaki
country: Japan
facility: St. Marianna University
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Saga
country: Japan
facility: Saga University
city: Tokushima
country: Japan
facility: Tokushima University
city: Tokyo
country: Japan
facility: Juntendo University
city: Tokyo
country: Japan
facility: Kyorin University
Study officials:
References:
citation: 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.
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 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.
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 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.