Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease (Challenge)

Inha University Hospital

Status and phase

Unknown

Phase 4

Conditions

Cerebral Small Vessel Disease

Treatments

Drug: aspirin

Drug: cilostazol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01932203

20130006

Details and patient eligibility

About

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

Full 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.

Enrollment

255 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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