The Impact of Anti-thrombosis on Cerebral Microbleeds and... | NCT03571763

Studies
The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke Patients

NCT03571763

Sponsor

General Hospital of Shenyang Military Region

Status

Recruiting

Last Update Posted

Apr 27, 2026Actual

Enrollment

1,875Estimated

Phase

Not provided

Conditions

Ischemic Stroke

Interventions

SWI sequence

Countries

China

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

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Jun 5, 2018

First Submission Date that Met QC Criteria

Jun 17, 2018

First Posted Date

Jun 28, 2018Actual

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

Apr 22, 2026

Last Update Posted Date

Apr 27, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hui-Sheng Chen, Director of neurological department, General Hospital of Shenyang Military RegionPrincipal Investigator

Lead Sponsor

General Hospital of Shenyang Military RegionOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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 prospective cohort study is to investigate whether antithrombotic therapy in the secondary prevention of ischemic stroke increases the risk of the emerging CMBs and whether the change is associated with an increased risk of intracranial hemorrhage, providing an imaging evidence for individualized antithrombotic therapy in such patients.

Detailed Description

Cerebral microbleeds（CMBs） is a subclinical lesion caused by microvascular disease in the brain, characterized by microleakage of blood. About 30% of ischemic stroke patients, 40% of the healthy people over 80 years old, and 60% of intracranial hemorrhage patients have microbleeds. With the development of imaging technology, clinically more and more patients have found microbleeds in the brain. How these patients are treated with antithrombotic drugs is not yet clear and is in urgent need of evidence. There are only a few prospective cohort studies to determine whether antithrombotic therapy increases the risk of intracranial hemorrhage in ischemic stroke patients with CMBs, but the results are uncertain. More importantly, whether antithrombotic therapy increases the incidence of the emerging CMBs, and whether the change of increased microbleeds is associated with increased intracranial hemorrhage has not been reported.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,875Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
acute ischemic stroke patient		acute ischemic stroke patient acute ischemic stroke patient Patient age ≥18 years .Acute ischemic stroke patient confirmed by imaging(SWI sequence) .Time of onset: within 3 months	Other: SWI sequence

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SWI sequence	Other	Acute ischemic stroke patient confirmed by SWI sequence	acute ischemic stroke patient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all cerebral bleeding events	incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI	360 days

Secondary Outcomes

Measure	Description	Time Frame
all cerebral bleeding events	incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI	180 days
proportion of mRS 0-1.	the minimum and maximum values of modified Rankin Score (mRS) are 0 and 6, respectively; higher score mean a worse outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient age ≥18 years;
Acute ischemic stroke patient confirmed by imaging;
Time of onset: within 3 months;
Baseline SWI sequence is completed before starting the secondary prevention of ischemic stroke;
Baseline SWI sequence must have at least one CMB ;
NIHSS≤10

Exclusion Criteria:

MRI contraindication;
Hemorrhagic transformation after acute Ischemic stroke;
Contraindication for antiplatelet or anticoagulation therapy;
Severe head trauma or intracranial hemorrhage occurred in the past six months;
obvious coagulopathy;
Other intracranial lesions associated with (such as tumor, cerebral vascular malformation);
other unqualified patients judged by the investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ischemic stroke patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
chen huisheng, doctor	Contact	86-24-28897511		chszh@aliyun.com
wang xinhong, doctor	Contact	15309885658		450341972@qq.com

Overall Officials

Name	Affiliation	Role
chen huisheng, doctor	General Hospital of Shenyang Military Region	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Hospital of ShenYang Military Region	Recruiting	Shenyang			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke
D002543	Cerebral Hemorrhage

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided