Cerebral Small Vessel Disease
Conditions
Keywords
Cerebral small vessel disease, Leukoaraiosis, Magnetic Resonance Imaging, Diffusion Tensor Imaging
Brief summary
There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease.
Detailed description
The primary objective of this study is to compare the efficacy of aspirin and cilostazol on volume of white matter changes in cerebral small vessel disease. The secondary objectives are to compare the impact of aspirin and cilostazol on DTI parameters, lacune, microbleeds, brain atrophy, cognition, depression, neurologic signs, gait, urination, and activities of daily living. We also investigate risk factors associated with progression of cerebral small vessel disease.
Interventions
DRUGaspirin
100mg once a day
DRUGcilostazol
200mg once a day
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Inha University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 50 to 85 years of age * He/She can walk to the hospital (walker or cane is permissible). * Cerebral small vessel disease is observed on brain MRI. 1\) presence of one or more lacunar infarction and 2) moderate or severe confluent 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of white matter changes (WMCs) | baseline, week 104 | Measure change of WMC on brain MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| brain volume and cortical thickness | baseline and week 104 | Low score means tissue damage. |
| Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging | baseline and week 104 | High MD and low FA means tissue damage. |
| Number of lacunes | baseline and week 104 | High number means tissue damage. |
| number of microbleeds | baseline and week 104 | High number means tissue damage. |
| Mini-Mental State Examination | baseline, week 52, and week 104 | Measure global cognition. Score range is 0-30. Higher score means good cognition. |
| Neurocognitive test | baseline, week 52, and week 104 | Seoul Verbal Learning Test, Boston Naming test-short form, ROCF copy, animal fluency, phonemic fluency, Stroop test, Digit-symbol test, Trail making test |
| Clinical Dementia Rating scale-sum of boxes | baseline, week 52, and week 104 | Measure global cognition. Score range is 0-18. Higher score means good cognition. |
| King's Health Questionnaire | baseline, week 42, and week 104 | Measure voiding function. Higher score means bad function. |
| Timed UP and Go (TUG) test | basline, week 52, and week 104 | Measure gait. Higher score means bad gait. |
| Adverse event | baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104 | measure any adverse events |
| Geriatric Depression Scale-Short form | baseline, week 52, and week 104 | Measure depression. Score range is 0-15. Higher score means depression. |
| Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) | baseline, week 52, and week 104 | Measure abnormal behavior. Score range is 0-144. Higher score means severe abnormal behavior. |
| Bayer Activities of Daily Living | baseline, week 52, and week 104 | Measure instrumental activities of daily living (ADL). Score range is 1-10. Higher score means bad ADL. |
| Barthel Index | baseline, week 52, and week 104 | Measure physical ADL. Score range is 0-20. Higher score means good physical ADL. |
| Pyramidal and Extrapyramidal Scale (PEPS) | baseline, week 52, and week 104 | Measure neurologic signs. Score range is 0-60. Higher score means many abnormal neurologic signs. |
Other
| Measure | Time frame | Description |
|---|---|---|
| All ischemic stroke event | week 104 | cerebral infarction and transient ischemic attack |
| All vascular events | week 104 | including ischemic stroke, transient ischemic attack, myocardial infarction, angina pectoris, cerebral venous thrombosis, pulmonary embolism, symptomatic deep vein thrombosis, symptomatic peripheral artery occlusion, other vascular occlusion, and any revascularization procedure |
Countries
South Korea
Outcome results
None listed