Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease

• Status: Unknown status
• Trial end date: 2019-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inha University Hospital
• Collaborator: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Aspirin; Cilostazol; Glucuronyl glucosamine glycan sulfate

Criteria

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