Cerebrovascular and Cardiovascular DiseasesBAT2NCT02889653
The Bleeding With Antithrombotic Therapy Study 2
An observational study of Cerebrovascular and Cardiovascular Diseases, run by National Cerebral and Cardiovascular Center, Japan at 9 sites in Japan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular and Cardiovascular Diseases
- What is being tested?
- Any oral antithrombotics (antiplatelets or anticoagulants)
- Type of treatment
- Pill or oral medicine
- How many people
- 5,306 participants
- Where
- 9 sitesJapan
- Study dates
- Oct 2016to Mar 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- MRI contraindication
- Any condition that in the opinion of the responsible physician or investigator that renders the patient unsuitable for the study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
National Hospital Organization Kyushu Medical Center
Fukuoka
St. Marianna University
Kawasaki
Kobe City Medical Center General Hospital
Kobe
National Hospital Organization Nagoya Medical Center
Nagoya
Saga University
Saga
National Cerebral and Cardiovascular Center
Suita, Osaka, 5658565
Tokushima University
Tokushima
Juntendo University
Tokyo
Kyorin University
Tokyo
About this study
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.
- Being tested
- Any oral antithrombotics (antiplatelets or anticoagulants)
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any oral antithrombotics (antiplatelets or anticoagulants)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
ISTH major bleeding
Measured: within 2 years
Secondary outcomes (3)
Clinically relevant non-major bleeding
Measured: within 2 years
Hemorrhagic event details
Measured: within 2 years
Ischemic events and those details
Measured: within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2020
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular and Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,306 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- National Cerebral and Cardiovascular Center, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development
- Responsible party
- Principal investigator, Kazunori Toyoda, National Cerebral and Cardiovascular Center, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889653
- Sponsor's protocol ID
- 16ek0210055h
- Other IDs
- 000023669
- Acronym
- BAT2
- Status last verified
- Nov 2023
- First submitted
- 30 Aug 2016
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27531346Takagi 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.
PubMed 33598561Tanaka 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.
PubMed 35253443Miwa K, Tanaka K, Koga M, Tanaka K, Yakushiji Y, Sasaki M, Kudo K, Shiozawa M, Yoshimura S, Ihara M, Fujimoto S, Hoshino H, Kamiyama K, Kawano H, Nagasawa H, Nagakane Y, Nishiyama K, Yagita Y, Yoshimura S, Hirano T, Toyoda K; BAT2 Investigators. Prediction Model to Optimize Long-Term Antithrombotic Therapy Using Covert Vascular Brain Injury and Clinical Features. Stroke. 2025 Sep;56(9):2605-2616. doi: 10.1161/STROKEAHA.125.050859. Epub 2025 Jun 19.
PubMed 40534562
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bleeding With Antithrombotic Therapy Study 2
- ClinicalTrials.gov ID
- NCT02889653
- Acronym / sponsor ID
- BAT2 / 16ek0210055h
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,306 participants (actual)
- Lead sponsor
- National Cerebral and Cardiovascular Center, JapanUniversity, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- MRI contraindication
- Any condition that in the opinion of the responsible physician or investigator that renders the patient unsuitable for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any oral antithrombotics (antiplatelets or anticoagulants) | Drug | – |
Primary outcome
ISTH major bleeding
Time frame: within 2 years
3 secondary outcomes
Clinically relevant non-major bleeding
Time frame: within 2 years
Hemorrhagic event details
Time frame: within 2 years
Ischemic events and those details
Time frame: within 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Results publication: PubMed 27531346Koga 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.
- Results publication: PubMed 33598561Takagi 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.
- Results publication: PubMed 35253443Tanaka 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.
- Derived from this study: PubMed 40534562Miwa K, Tanaka K, Koga M, Tanaka K, Yakushiji Y, Sasaki M, Kudo K, Shiozawa M, Yoshimura S, Ihara M, Fujimoto S, Hoshino H, Kamiyama K, Kawano H, Nagasawa H, Nagakane Y, Nishiyama K, Yagita Y, Yoshimura S, Hirano T, Toyoda K; BAT2 Investigators. Prediction Model to Optimize Long-Term Antithrombotic Therapy Using Covert Vascular Brain Injury and Clinical Features. Stroke. 2025 Sep;56(9):2605-2616. doi: 10.1161/STROKEAHA.125.050859. Epub 2025 Jun 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular and Cardiovascular Diseases, run by National Cerebral and Cardiovascular Center, Japan at 9 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ISTH major bleeding (time frame: within 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02889653, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.