There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
255
100mg once a day
200mg once a day
Myongji Hospital
Goyang-si, Gyeonggi-do, South Korea
National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Volume of white matter changes (WMCs)
Measure change of WMC on brain MRI
Time frame: baseline, week 104
Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging
High MD and low FA means tissue damage.
Time frame: baseline and week 104
Number of lacunes
High number means tissue damage.
Time frame: baseline and week 104
number of microbleeds
High number means tissue damage.
Time frame: baseline and week 104
brain volume and cortical thickness
Low score means tissue damage.
Time frame: baseline and week 104
Mini-Mental State Examination
Measure global cognition. Score range is 0-30. Higher score means good cognition.
Time frame: baseline, week 52, and week 104
Neurocognitive test
Seoul Verbal Learning Test, Boston Naming test-short form, ROCF copy, animal fluency, phonemic fluency, Stroop test, Digit-symbol test, Trail making test
Time frame: baseline, week 52, and week 104
Clinical Dementia Rating scale-sum of boxes
Measure global cognition. Score range is 0-18. Higher score means good cognition.
Time frame: baseline, week 52, and week 104
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Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Hwaseong-si, Gyeonggi-do, South Korea
Wonkwang University Iksan Hospital
Iksan, Jeollabuk-do, South Korea
Hallym University Medical Center
Anyang, South Korea
Bucheon St.Mary's Hospital
Bucheon-si, South Korea
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Eulji University School of Medicine
Daejeon, South Korea
Konyang University Hospital
Daejeon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
...and 9 more locations
King's Health Questionnaire
Measure voiding function. Higher score means bad function.
Time frame: baseline, week 42, and week 104
Geriatric Depression Scale-Short form
Measure depression. Score range is 0-15. Higher score means depression.
Time frame: baseline, week 52, and week 104
Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)
Measure abnormal behavior. Score range is 0-144. Higher score means severe abnormal behavior.
Time frame: baseline, week 52, and week 104
Bayer Activities of Daily Living
Measure instrumental activities of daily living (ADL). Score range is 1-10. Higher score means bad ADL.
Time frame: baseline, week 52, and week 104
Barthel Index
Measure physical ADL. Score range is 0-20. Higher score means good physical ADL.
Time frame: baseline, week 52, and week 104
Pyramidal and Extrapyramidal Scale (PEPS)
Measure neurologic signs. Score range is 0-60. Higher score means many abnormal neurologic signs.
Time frame: baseline, week 52, and week 104
Timed UP and Go (TUG) test
Measure gait. Higher score means bad gait.
Time frame: basline, week 52, and week 104
Adverse event
measure any adverse events
Time frame: baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104