Cerebral Small Vessel Disease (CSVD)
Conditions
Interventions
experimental group:Aspirin combined use of ginkgo biloba ester
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 50 - 80 years old, with independent daily living ability (mRS < 2); 2. Have the ability to give informed consent; 3. The clinical manifestation is a lacunar cerebral infarction with minor stroke (NIHSS <= 2). The brain CT/MRI performed simultaneously shows one of the following characteristics: a. The most recent acute subcortical infarction (in terms of time and location); b. MR FLAIR, T2 or T1 MR imaging or CT brain imaging shows a recent subcortical infarction at the relevant location within the last 1 month (i.e., no cavity or flow void effect, possibly with mild swelling, unclear boundaries); c. MR FLAIR, T2 or T1 magnetic resonance imaging or CT brain imaging shows a new subcortical infarction at the relevant location between the scan before or after the stroke and the scan several hours to several days after the stroke; d. Or if there is no visible acute subcortical infarction on MR or CT brain imaging, and no other pathology as the cause of the stroke (i.e., no acute cortical infarction, no acute cerebral hemorrhage, no stroke mimicking diseases such as tumors, subdural hematoma). 4. The time interval from the onset of stroke to randomization should be no more than 30 days.
Exclusion criteria
Exclusion criteria: 1. Other active neurological disorders, such as recurrent seizures, multiple sclerosis, brain tumors (except for epilepsy that was well controlled before the stroke, single epileptic-like seizures during a stroke attack, or induced epileptic-like seizures); 2. mRS >=3; 3. Diagnosed with cognitive impairment; 4. Low blood pressure, with systolic blood pressure (SBP) less than 100 mmHg; 5. Unable to swallow the pills; 6. Surgery is planned to be performed during the trial period. 7. Other concurrent life-threatening diseases; 8. Unable to conduct subsequent follow-up visits; 9. History of drug overdose, history of attempted suicide, and history of severe active mental illness; 10. Pregnant women or lactating women, as well as women of childbearing age who have not taken contraceptive measures; 11. Renal function impairment (creatinine clearance rate = 3 times the upper limit or AST = 3 times the upper limit); 13. Currently, be participating in another clinical trial study of a drug. 14. Unable to tolerate MRI or having contraindications for MRI; 15. Those who are allergic or intolerant to ginkgo-based medications. 16. Cardiovascular-induced stroke; 17. Merge any degree of cerebral vascular stenosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| tolerance;MRI biomarker;The incidence rate of the 48-week composite endpoint;EEG; | — |
Countries
China
Contacts
Public ContactHao Yong
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed