Actively Recruiting
Antiplatelet Therapy and Endothelial-stabilizing Agents in Cerebral Small Vessel Diseases
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-03-28
300
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating cerebral small vessel disease (cSVD), a common condition linked with aging that affects small blood vessels in the brain and can lead to strokes and cognitive problems. This prospective cohort study in China aims to evaluate the effects of different antiplatelet agents, including cilostazol, on cSVD and retinal blood vessels in patients with recent small subcortical infarcts or white matter hyperintensities (WMH). Participants will receive antiplatelet treatments such as aspirin, clopidogrel, or a combination of cilostazol and isosorbide mononitrate. The study includes patients with either recent small subcortical infarcts or WMH graded 2-3 on the Fazekas scale. Treatments are assessed over a 6-month follow-up period to monitor their impact on brain and retinal health. During the study, participants undergo neurological assessments at baseline, 1 week, 3 months, and 6 months. Brain MRI scans are done at baseline and 6 months. Cognitive function, daily living activities, and movement disorder ratings are also evaluated. Researchers monitor for bleeding events and occurrences of ischemic stroke or transient ischemic attacks while assessing changes in retinal vasculature as the primary outcome over six months.
CONDITIONS
Brief Title
Antiplatelet Therapy and Endothelial-stabilizing Agents in Cerebral Small Vessel Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 79 years
- Recent small subcortical infarct within 3 weeks prior to enrollment or white matter hyperintensities graded 2-3 on Fazekas scale
- No signs or symptoms of cortical dysfunction such as aphasia, apraxia, agnosia, agraphia, or homonymous visual field defect
- Modified Rankin score of 4 or less
- No other pathology in the parent artery at the site of the penetrating artery origin
- No ipsilateral cervical carotid stenosis (30% or more) or vertebral artery stenosis (30% or more) as assessed by imaging
- No major-risk cardioembolic sources requiring anticoagulation or other specific therapy
- Willingness to attend follow-up visits and available by phone
- Ability to understand the study purpose and requirements and provide informed consent
You will not qualify if you...
- Intracranial aneurysms needing surgical treatment or significant active neurological illness (e.g., seizures, multiple sclerosis, intracranial tumor except meningioma, intracranial vascular malformation)
- Active cardiac disease such as atrial fibrillation, recent myocardial infarction, active angina, or symptomatic cardiac failure
- History of any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural)
- Allergy or contraindication to aspirin, clopidogrel, cilostazol, isosorbide mononitrate, or statins
- Active peptic ulcer disease, major bleeding within 30 days, bleeding disorders, low platelet count, abnormal clotting, substance abuse, uncontrolled severe hypertension, severe liver impairment, or severe renal dysfunction
- Major surgery within 30 days prior or planned within 1 year after enrollment
- Dementia or psychiatric problems preventing reliable evaluation or follow-up
- Conditions limiting survival to less than 1 year
- Pregnancy, breastfeeding, planning pregnancy, or unwillingness to use contraception during the study
- Inability to tolerate or contraindication to MRI
- Enrollment in conflicting clinical studies
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants receive antiplatelet therapy with agents such as Aspirin, Clopidogrel, or Cilostazol plus Isosorbide Mononitrate to evaluate their effects on cerebral small vessel disease and retinal vasculature.
Visits at baseline, 1 week, 3 months, and 6 months including neurological, cognitive, and functional assessments; Brain MRI at baseline and 6 months
Trial Site Locations
Total: 1 location
1
the First affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210001
Actively Recruiting
Research Team
Z
Zhaolu Wang, MD
X
Xinyu Chen
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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