Investigating the effects of anti-thrombosis on brain microbleeds in stroke patients

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

This study is testing whether blood-thinning medications affect the risk of new brain microbleeds in stroke patients.

Quick facts

• Study type: Observational
• Enrollment: 1875 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (other)
• Locations: 1 site (Shenyang)
• Trial ID: NCT03571763 on ClinicalTrials.gov

What this trial studies

This prospective cohort study aims to explore the relationship between antithrombotic therapy and the occurrence of cerebral microbleeds (CMBs) in patients who have experienced an ischemic stroke. It will assess whether such therapy increases the risk of new CMBs and whether these changes correlate with a higher incidence of intracranial hemorrhage. The study will utilize advanced imaging techniques to gather evidence that could inform personalized antithrombotic treatment strategies for these patients. By focusing on a specific patient population, the research seeks to clarify the risks associated with antithrombotic medications in the context of ischemic stroke.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced an acute ischemic stroke within the last three months and have at least one cerebral microbleed.

Not a fit: Patients with contraindications for MRI or antithrombotic therapy, or those with recent hemorrhagic events, will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more tailored and safer antithrombotic therapies for ischemic stroke patients, potentially reducing the risk of intracranial hemorrhage.

How similar studies have performed: While there are few prospective cohort studies on this topic, the results have been uncertain, indicating that this study may provide novel insights into the effects of antithrombotic therapy on cerebral microbleeds.

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

Where this trial is running

Shenyang

• General Hospital of ShenYang Military Region — Shenyang, China (RECRUITING)

Study contacts

• Study coordinator: chen huisheng, doctor

Conditions: Ischemic Stroke, Cerebral Hemorrhage, anti-thrombosis