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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023669
Receipt No. R000027259
Scientific Title The Bleeding with Antithrombotic Therapy Study 2
Date of disclosure of the study information 2016/08/18
Last modified on 2017/11/11

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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
Middle name
Last name Kazunori Toyoda, MD, PhD
Organization National Cerebral and Cardiovascular Center
Division name Department of Stroke and Cerebrovascular Diseases
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka 565-8565, Japan
TEL 06-6833-5012
Email toyoda@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoichiro Sato, MD, PhD
Organization National Cerebral and Cardiovascular Center
Division name Division of Cerebrovascular Medicine, Department of Stroke and Cerebrovascular Diseases
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka 565-8565, Japan
TEL 06-6833-5012
Homepage URL http://bat2.stroke-ncvc.jp
Email bat2@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

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
Address
Tel
Email

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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 03 Day
Last follow-up date
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
2017 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.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


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