The Bleeding With Antithrombotic Therapy Study 2 | NCT02889653

Studies
The Bleeding With Antithrombotic Therapy Study 2

NCT02889653

Sponsor

National Cerebral and Cardiovascular Center, Japan

Status

Completed

Last Update Posted

Nov 9, 2023Actual

Enrollment

5,306Actual

Phase

Not provided

Conditions

Cerebrovascular and Cardiovascular Diseases

Interventions

Any oral antithrombotics (antiplatelets or anticoagulants)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
000023669	Other Identifier	UMIN Clinical Trials Registry

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Mar 2020Actual

Completion Date

Mar 2021Actual

First Submitted Date

Aug 30, 2016

First Submission Date that Met QC Criteria

Aug 30, 2016

First Posted Date

Sep 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2023

Last Update Posted Date

Nov 9, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kazunori Toyoda, Director and Chair, Department of Stroke and Cerebrovascular Diseases, National Cerebral and Cardiovascular Center, JapanPrincipal Investigator

Lead Sponsor

National Cerebral and Cardiovascular Center, JapanOTHER

Collaborators

Name	Class
Japan Agency for Medical Research and Development	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,306Actual

Name	Type	Description	Arm Group Labels	Other Names
Any oral antithrombotics (antiplatelets or anticoagulants)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ISTH major bleeding		within 2 years

Secondary Outcomes

Measure	Description	Time Frame
Clinically relevant non-major bleeding		within 2 years
Hemorrhagic event details		within 2 years
Ischemic events and those details

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cerebral and Cardiovascular Center		Suita	Osaka	5658565	Japan
National Hospital Organization Kyushu Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27531346	Result	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.
33598561

ID	Term
D006401	Hematologic Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses