Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease
- Registration Number
- NCT01932203
- Lead Sponsor
- Inha University Hospital
- Brief Summary
There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 255
-
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.
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description aspirin aspirin aspirin 100mg by mouth once a day for 104 weeks Cilostazol cilostazol Pletaal SR 200mg by mouth once a day for 104 weeks
- Primary Outcome Measures
Name Time Method Volume of white matter changes (WMCs) baseline, week 104 Measure change of WMC on brain MRI
- Secondary Outcome Measures
Name Time Method Number of lacunes baseline and week 104 High number means tissue damage.
Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging baseline and week 104 High MD and low FA means tissue damage.
number of microbleeds baseline and week 104 High number means tissue damage.
brain volume and cortical thickness baseline and week 104 Low score means tissue damage.
Mini-Mental State Examination baseline, week 52, and week 104 Measure global cognition. Score range is 0-30. Higher score means good cognition.
Neurocognitive test 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-sum of boxes baseline, week 52, and week 104 Measure global cognition. Score range is 0-18. Higher score means good cognition.
Barthel Index baseline, week 52, and week 104 Measure physical ADL. Score range is 0-20. Higher score means good physical ADL.
King's Health Questionnaire baseline, week 42, and week 104 Measure voiding function. Higher score means bad function.
Geriatric Depression Scale-Short form baseline, week 52, and week 104 Measure depression. Score range is 0-15. Higher score means depression.
Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) baseline, week 52, and week 104 Measure abnormal behavior. Score range is 0-144. Higher score means severe abnormal behavior.
Bayer Activities of Daily Living baseline, week 52, and week 104 Measure instrumental activities of daily living (ADL). Score range is 1-10. Higher score means bad ADL.
Timed UP and Go (TUG) test basline, week 52, and week 104 Measure gait. Higher score means bad gait.
Pyramidal and Extrapyramidal Scale (PEPS) baseline, week 52, and week 104 Measure neurologic signs. Score range is 0-60. Higher score means many abnormal neurologic signs.
Adverse event baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104 measure any adverse events
Trial Locations
- Locations (19)
Dongtan Sacred Heart Hospital, Hallym University College of Medicine
🇰🇷Hwaseong-si, Gyeonggi-do, Korea, Republic of
Hallym University Medical Center
🇰🇷Anyang, Korea, Republic of
Eulji University School of Medicine
🇰🇷Daejeon, Korea, Republic of
Chungang University Hospital
🇰🇷Seoul, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical
🇰🇷Incheon, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon, Korea, Republic of
Dong-A University Hospital
🇰🇷Pusan, Korea, Republic of
Wonkwang University Iksan Hospital
🇰🇷Iksan, Jeollabuk-do, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Myongji Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Bucheon St.Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of