Overview

This trial is active, not recruiting.

Condition cerebral small vessel disease
Treatments aspirin, cilostazol
Phase phase 4
Sponsor Inha University Hospital
Collaborator Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date July 2013
End date August 2018
Trial size 255 participants
Trial identifier NCT01932203, 20130006

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
aspirin 100mg by mouth once a day for 104 weeks
aspirin
100mg once a day
(Experimental)
Pletaal SR 200mg by mouth once a day for 104 weeks
cilostazol Pletaal SR
200mg once a day

Primary Outcomes

Measure
Volume of white matter changes (WMCs)
time frame: baseline, week 104

Secondary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants from 50 years up to 85 years old.

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 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 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

Additional Information

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
Principal investigator Seong Hye Choi, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Inha University Hospital.