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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 30, 2025

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

  • Other: SWI sequence
    • Acute ischemic stroke patient confirmed by SWI sequence

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • all cerebral bleeding events
    • Time Frame: 180 days
    • incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI
  • proportion of mRS 0-1.
    • Time Frame: 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 microbleeds
    • Time Frame: 180 、360 days
    • cerebral microbleeds, determined by MRI
  • proportion of cerebral hemorrhage
    • Time Frame: 180、360 days
    • cerebral hemorrhage, determined by MRI
  • the occurence of stroke or other vascular events
    • Time Frame: 180、360 days
  • the occurence of death due to any cause
    • Time Frame: 180、360 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • General Hospital of Shenyang Military Region
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hui-Sheng Chen, Director of neurological department – General Hospital of Shenyang Military Region
  • Overall Official(s)
    • chen huisheng, doctor, Study Director, General Hospital of Shenyang Military Region
  • Overall Contact(s)
    • chen huisheng, doctor, 86-24-28897511, chszh@aliyun.com

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