About this trial
Cerebral small vessel disease (cSVD) is a common accompaniment of aging. Recent small subcortical (or lacunar) infarcts (i.e. symptomatic cSVD) and white matter hyperintensities are typical cSVD lesions on neuroimaging. cSVD causes about a quarter of ischaemic strokes and related with cognitive dysfunction. However, few studies are available so far to especially explore the treatment of cSVD. Endothelial dysfunction plays an important part in cSVD. Cilostazol and isosorbide mononitrate have endothelial protective function. We designed this prospective cohort study in China, aiming to evaluate the effect of different antiplatelet agents (e.g. Cilostazol) on cSVD and retina in patients with cSVD (recent small subcortical infarcts or WMH, respectively).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 30 years and ≤ 79 years.
A recent small subcortical infarct that occurred within 3 weeks prior to randomization; or patient with whiter matter hyperintensities with a 2-3 grading on Fazekas scale.
Absence of signs or symptoms of cortical dysfunction, such as aphasia, apraxia, agnosia, agraphia, homonymous visual field defect.
Modified Rankin score of ≤ 4.
Disqualifiers
Intracranial aneurysms that need surgical treatment. Other significant active neurological illness e.g seizures, multiple sclerosis, intracranial tumor (except meningioma) or any intracranial vascular malformation.
Active cardiac disease (atrial fibrillation, myocardial infarct in last six months, active angina, symptomatic cardiac failure).
History of any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural).
Known allergy or contraindication to aspirin, clopidogrel, cilostazol, isosorbide mononitrate or statin.
Trial population
Patients with a recent small subcortical infarct that occurred within 3 weeks prior to randomization, or patient with whiter matter hyperintensities with a 2-3 grading on Fazekas scale will be recruited.
Trial design
Cohort
Prospective
Treatments tested in this trial
Clopidogrel
DrugPatients will take Clopidogrel
Aspirin
DrugPatients will take Rivaroxaban
Cilostazol + Isosorbide Mononitrate
DrugPatients will take Cilostazol plus Isosorbide Mononitrate
Treatment groups
Trial outcomes
Primary outcomes
the impact of different antiplatelet agents on retinal vasculature.
retinal vasculature will be assessed by optical coherence tomography and optical coherence tomography angiography.
Secondary outcomes
systemic or intracranial bleeding
occurrence of ischemic stroke or transient ischemic attack
Neurological function
Neurological function will be assessed by NIHSS (National institute of health stroke scale)
Brain MRI (magnetic resonance imaging)
Brain MRI to evaluate whiter matter hyperintensities.
Sponsors and contacts
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