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

NCT ID: NCT03571763

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1875 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2026-12-30

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.

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

SWI sequence

Intervention Type: OTHER

Acute ischemic stroke patient confirmed by SWI sequence

Interventions

SWI sequence

Acute ischemic stroke patient confirmed by SWI sequence

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Director of neurological department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

chen huisheng, doctor

Role: STUDY_DIRECTOR

General Hospital of Shenyang Military Region

Locations

General Hospital of ShenYang Military Region

Shenyang, , China

Site Status: RECRUITING

Countries

China

Central Contacts

chen huisheng, doctor

Role: CONTACT

chszh@aliyun.com

86-24-28897511

wang xinhong, doctor

Role: CONTACT

450341972@qq.com

15309885658

Facility Contacts

Cheng Xia, Ph.D

Role: primary

xiacheng1975@sina.com

Other Identifiers

k(2017)33

Identifier Type: -

Identifier Source: org_study_id