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

Recruiting

• Conditions: Ischemic Stroke
• Interventions: Other: SWI sequence

• Registration Number: NCT03571763
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Study Timeline

• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-17
• Study First Posted: 2018-06-28
• Study Start: 2018-08-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1875

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
acute ischemic stroke patient	SWI sequence	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

Primary Outcome Measures

Name	Time	Method
all cerebral bleeding events	360 days	incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI

Secondary Outcome Measures

Name	Time	Method
proportion of cerebral microbleeds	180 、360 days	cerebral microbleeds, determined by MRI
all cerebral bleeding events	180 days	incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI
proportion of mRS 0-1.	180、360 days	the minimum and maximum values of modified Rankin Score (mRS) are 0 and 6, respectively; higher score mean a worse outcome
proportion of cerebral hemorrhage	180、360 days	cerebral hemorrhage, determined by MRI
the occurence of stroke or other vascular events	180、360 days
the occurence of death due to any cause	180、360 days

Trial Locations

Locations (1)

General Hospital of ShenYang Military Region; 🇨🇳 ShenYang, China