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

The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke Patients: Prospective, Multi-center, Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03571763
Enrollment
1875
Registered
2018-06-28
Start date
2018-08-01
Completion date
2026-12-30
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

Cerebral Hemorrhage, anti-thrombosis

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.

Interventions

OTHERSWI sequence

Acute ischemic stroke patient confirmed by SWI sequence

Sponsors

General Hospital of Shenyang Military Region
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patient age ≥18 years; 2. Acute ischemic stroke patient confirmed by imaging; 3. Time of onset: within 3 months; 4. Baseline SWI sequence is completed before starting the secondary prevention of ischemic stroke; 5. Baseline SWI sequence must have at least one CMB ; 6. NIHSS≤10

Exclusion criteria

1. MRI contraindication; 2. Hemorrhagic transformation after acute Ischemic stroke; 3. Contraindication for antiplatelet or anticoagulation therapy; 4. Severe head trauma or intracranial hemorrhage occurred in the past six months; 5. obvious coagulopathy; 6. Other intracranial lesions associated with (such as tumor, cerebral vascular malformation); 7. other unqualified patients judged by the investigator

Design outcomes

Primary

MeasureTime frameDescription
all cerebral bleeding events360 daysincidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI

Secondary

MeasureTime frameDescription
all cerebral bleeding events180 daysincidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI
proportion of mRS 0-1.180、360 daysthe minimum and maximum values of modified Rankin Score (mRS) are 0 and 6, respectively; higher score mean a worse outcome
proportion of cerebral microbleeds180 、360 dayscerebral microbleeds, determined by MRI
proportion of cerebral hemorrhage180、360 dayscerebral hemorrhage, determined by MRI
the occurence of stroke or other vascular events180、360 days
the occurence of death due to any cause180、360 days

Countries

China

Contacts

CONTACTchen huisheng, doctor
chszh@aliyun.com86-24-28897511
CONTACTwang xinhong, doctor
450341972@qq.com15309885658
STUDY_DIRECTORchen huisheng, doctor

General Hospital of Shenyang Military Region

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026