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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03571763
• Other study ID #: k(2017)33
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2023
• Source: General Hospital of Shenyang Military Region
• Contact: chen huisheng, doctor
• Phone: 86-24-28897511
• Email: chszh[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1875
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Hemorrhage
• Intracranial Hemorrhages
• Ischemia
• Ischemic Stroke
• Stroke
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
China	General Hospital of ShenYang Military Region	ShenYang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cerebral bleeding events	incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI	360 days
Secondary	all cerebral bleeding events	incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI	180 days
Secondary	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	180?360 days
Secondary	proportion of cerebral microbleeds	cerebral microbleeds, determined by MRI	180 ?360 days
Secondary	proportion of cerebral hemorrhage	cerebral hemorrhage, determined by MRI	180?360 days
Secondary	the occurence of stroke or other vascular events		180?360 days
Secondary	the occurence of death due to any cause		180?360 days