Clinical Trial: Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multicenter, Randomized, Double Blind Study to Compare the Efficacy Between Cilostazol and Aspirin on White Matter Changes by Cerebral Small Vessel Disease

Brief Summary: There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebal small vessel disease.

Detailed Summary:

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.


Sponsor: Inha University Hospital

Current Primary Outcome: Volume of white matter changes (WMCs) [ Time Frame: baseline, week 104 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mean diffusivity and Fraction Anisotrophy on Diffusion Tensor Imaging [ Time Frame: baseline and week 104 ]
  • Number of lacunes [ Time Frame: baseline and week 104 ]
  • number of microbleeds [ Time Frame: baseline and week 104 ]
  • brain volume and cortical thickness [ Time Frame: baseline and week 104 ]
  • Mini-Mental State Examination [ Time Frame: baseline, week 52, and week 104 ]
  • Neurocognitive test [ Time Frame: 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 [ Time Frame: baseline, week 52, and week 104 ]
  • King's Health Questionnaire [ Time Frame: baseline, week 42, and week 104 ]
  • Geriatric Depression Scale-Short form [ Time Frame: baseline, week 52, and week 104 ]
  • Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) [ Time Frame: baseline, week 52, and week 104 ]
  • Bayer Activities of Daily Living [ Time Frame: baseline, week 52, and week 104 ]
  • Barthel Index [ Time Frame: baseline, week 52, and week 104 ]
  • Pyramidal and Extrapyramidal Scale (PEPS) [ Time Frame: baseline, week 52, and week 104 ]
  • Timed UP and Go (TUG) test [ Time Frame: baslien, week 52, and week 104 ]
  • Adverse event [ Time Frame: baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104 ]


Original Secondary Outcome: Same as current

Information By: Inha University Hospital

Dates:
Date Received: August 27, 2013
Date Started: July 2013
Date Completion: October 2018
Last Updated: September 23, 2016
Last Verified: September 2016