Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease

Cerebral Small Vessel Disease Clinical Trial

— Challenge  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01932203
• Other study ID #: 20130006
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 17, 2013
• Est. completion date: August 31, 2019

Study information

• Verified date: August 2019
• Source: Inha University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 255
• Est. completion date: August 31, 2019
• Est. primary completion date: August 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Small Vessel Disease
• Cerebral Small Vessel Diseases

Intervention

Drug:
• aspirin
100mg once a day
• cilostazol
200mg once a day

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang
Korea, Republic of	Bucheon St.Mary's Hospital	Bucheon
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	Eulji University School of Medicine	Daejeon
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	Myongji Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	National Health Insurance Corporation Ilsan Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Dongtan Sacred Heart Hospital, Hallym University College of Medicine	Hwaseong-si	Gyeonggi-do
Korea, Republic of	Wonkwang University Iksan Hospital	Iksan	Jeollabuk-do
Korea, Republic of	Gachon University Gil Medical	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Dong-A University Hospital	Pusan
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chungang University Hospital	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Inha University Hospital	Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All ischemic stroke event	cerebral infarction and transient ischemic attack	week 104
Other	All vascular events	including ischemic stroke, transient ischemic attack, myocardial infarction, angina pectoris, cerebral venous thrombosis, pulmonary embolism, symptomatic deep vein thrombosis, symptomatic peripheral artery occlusion, other vascular occlusion, and any revascularization procedure	week 104
Primary	Volume of white matter changes (WMCs)	Measure change of WMC on brain MRI	baseline, week 104
Secondary	Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging	High MD and low FA means tissue damage.	baseline and week 104
Secondary	Number of lacunes	High number means tissue damage.	baseline and week 104
Secondary	number of microbleeds	High number means tissue damage.	baseline and week 104
Secondary	brain volume and cortical thickness	Low score means tissue damage.	baseline and week 104
Secondary	Mini-Mental State Examination	Measure global cognition. Score range is 0-30. Higher score means good cognition.	baseline, week 52, and week 104
Secondary	Neurocognitive test	Seoul Verbal Learning Test, Boston Naming test-short form, ROCF copy, animal fluency, phonemic fluency, Stroop test, Digit-symbol test, Trail making test	baseline, week 52, and week 104
Secondary	Clinical Dementia Rating scale-sum of boxes	Measure global cognition. Score range is 0-18. Higher score means good cognition.	baseline, week 52, and week 104
Secondary	King's Health Questionnaire	Measure voiding function. Higher score means bad function.	baseline, week 42, and week 104
Secondary	Geriatric Depression Scale-Short form	Measure depression. Score range is 0-15. Higher score means depression.	baseline, week 52, and week 104
Secondary	Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)	Measure abnormal behavior. Score range is 0-144. Higher score means severe abnormal behavior.	baseline, week 52, and week 104
Secondary	Bayer Activities of Daily Living	Measure instrumental activities of daily living (ADL). Score range is 1-10. Higher score means bad ADL.	baseline, week 52, and week 104
Secondary	Barthel Index	Measure physical ADL. Score range is 0-20. Higher score means good physical ADL.	baseline, week 52, and week 104
Secondary	Pyramidal and Extrapyramidal Scale (PEPS)	Measure neurologic signs. Score range is 0-60. Higher score means many abnormal neurologic signs.	baseline, week 52, and week 104
Secondary	Timed UP and Go (TUG) test	Measure gait. Higher score means bad gait.	basline, week 52, and week 104
Secondary	Adverse event	measure any adverse events	baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104