Clinical trial NCT03571763: The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke Patients
Official title: The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke Patients: Prospective, Multi-center, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Keywords: Cerebral Hemorrhage
anti-thrombosis
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 1875
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ischemic stroke patients

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.

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

Primary outcomes:
measure: all cerebral bleeding events
timeFrame: 360 days
Secondary outcomes:
measure: all cerebral bleeding events
timeFrame: 180 days
measure: proportion of mRS 0-1.
timeFrame: 180、360 days
measure: proportion of cerebral microbleeds
timeFrame: 180 、360 days
measure: proportion of cerebral hemorrhage
timeFrame: 180、360 days
measure: the occurence of stroke or other vascular events
timeFrame: 180、360 days
measure: the occurence of death due to any cause
timeFrame: 180、360 days
Other outcomes:
Locations:
city: ShenYang
country: China
facility: General Hospital of ShenYang Military Region
Study officials:
affiliation: General Hospital of Shenyang Military Region
name: chen huisheng, doctor
role: STUDY_DIRECTOR
References: