Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0000928
- Lead Sponsor
- Inha University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 238
50 to 85 years of age
-He/She can walk to the hospital (walker or cane is permissible).
-Cerebral small vessel disease is oberved on brain MRI.
1) presence of one or more lacunar infarction and 2) moderate or severe confluenct leukoaraiosis (defined as grade 2 or 3 on a modified Fazekas scale): periventricular WMCs with cap or rims lager than 5mm and deep subcortical WMCs >10 mm in maximum diameter
-written informed consent
-Any patient with contraindication of antiplatelets
-Any patient with cardioembolic source
-Carotid bruit or large cerebral artery stenosis >50%
-Cortical infarction or subcortical infarction lager than 1.5 cm
-bleeding tendency
-chronic liver disease (AST or ALT >100 IL/L)
-chronic renal disease (Creatinine >3.0mg/dL)
-active gastrointestinal ulcer
-any patients with any severe or unstable medical disease that may prevent them from completing study requirements (i.e., unstable or severe asthma)
-Anemia (Hb <10g/dL) or thrombocytopenia
-Cardiac pacemaker or contraindication to MRI
-Pregnancy or breast-feeding
-drug or alcohol addiction
-Any other white matte disease (i.e., Multiple sclerosis, sarcoidosis, or brain irradiation, etc) or brain tumor
-Parkinson's disease, Alzheimer's disease or any other neurodegenerative disease
-any hearing or visual impairment that can disturb the efficient evaluation of the patient
-recent cerebral infarction with 3 months
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Volume of white matter changes (WMCs)
- Secondary Outcome Measures
Name Time Method Mean diffusivity and Fraction Anisotrophy on Diffusion Tensor Imaging;Number of lacunes;number of microbleeds;brain volume and cortical thickness;Mini-Mental State Examination;Neurocognitive test ;Clinical Dementia Rating scale;King's Health Questionnaire;Geriatric Depression Scale-Short form;Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI);Bayer Activities of Daily Living;Barthel Index ;Pyramidal and Extrapyramidal Scale (PEPS) ;Timed UP and Go (TUG) test