UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023669 |
|---|---|
| Receipt number | R000027259 |
| Scientific Title | The Bleeding with Antithrombotic Therapy Study 2 |
| Date of disclosure of the study information | 2016/08/18 |
| Last modified on | 2020/03/06 14:53:54 |
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Basic information
Public title
The Bleeding with Antithrombotic Therapy Study 2
Acronym
BAT2
Scientific Title
The Bleeding with Antithrombotic Therapy Study 2
Scientific Title:Acronym
BAT2
Region
| Japan |
Condition
Condition
Cerebrovascular and cardiovascular diseases
Classification by specialty
| Cardiology | Neurology | Geriatrics |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the incidence and severity of bleeding complications in patients with cerebrovascular and cardiovascular diseases treated with oral antithrombotic therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ISTH major bleeding
Key secondary outcomes
1. Clinically relevant non-major bleeding
2. Hemorrhagic event details
3. Ischemic events and those details
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with cerebrovascular or cardiovascular diseases who start or continue taking oral antithrombotics (antiplatelets and/or anticoagulants) to prevent vascular events
2. Patients who are able to receive MRI
3. Provision of written informed consent either directly or by a suitable surrogate
Key exclusion criteria
1. MRI contraindication
2. Any condition that in the opinion of the responsible physician or investigator that renders the patient unsuitable for the study
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Toyoda |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Stroke and Cerebrovascular Diseases
Zip code
565-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, Japan
TEL
06-6170-1070
toyoda@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Masahito |
| Middle name | |
| Last name | Takagi |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of Cerebrovascular Medicine, Department of Stroke and Cerebrovascular Diseases
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, Japan
TEL
06-6170-1070
Homepage URL
http://bat2.stroke-ncvc.jp
bat2@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, Japan
Tel
06-6170-1070
rec-office-ac@ncvc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
5367
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All participants will be registered along with clinical information and MRI at baseline; and be followed up at 6, 12, and 24 months.
Management information
Registered date
| 2016 | Year | 08 | Month | 18 | Day |
Last modified on
| 2020 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027259
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
