Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease
NCT ID: NCT01932203
Last Updated: 2019-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
255 participants
INTERVENTIONAL
2013-07-17
2019-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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aspirin
aspirin 100mg by mouth once a day for 104 weeks
aspirin
100mg once a day
Cilostazol
Pletaal SR 200mg by mouth once a day for 104 weeks
cilostazol
200mg once a day
Interventions
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aspirin
100mg once a day
cilostazol
200mg once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
85 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Inha University Hospital
OTHER
Responsible Party
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Inha University Hospital
Professor
Principal Investigators
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Seong Hye Choi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Locations
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Myongji Hospital
Goyang-si, Gyeonggi-do, South Korea
National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Hwaseong-si, Gyeonggi-do, South Korea
Wonkwang University Iksan Hospital
Iksan, Jeollabuk-do, South Korea
Hallym University Medical Center
Anyang, , South Korea
Bucheon St.Mary's Hospital
Bucheon-si, , South Korea
Soonchunhyang University Bucheon Hospital
Bucheon-si, , South Korea
Eulji University School of Medicine
Daejeon, , South Korea
Konyang University Hospital
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Inha University Hospital
Incheon, , South Korea
Gachon University Gil Medical
Incheon, , South Korea
Dong-A University Hospital
Pusan, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Asan Medical Center
Seoul, , South Korea
Chungang University Hospital
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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References
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Kwan J, Hafdi M, Chiang LLW, Myint PK, Wong LS, Quinn TJ. Antithrombotic therapy to prevent cognitive decline in people with small vessel disease on neuroimaging but without dementia. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD012269. doi: 10.1002/14651858.CD012269.pub2.
Kim BC, Youn YC, Jeong JH, Han HJ, Kim JH, Lee JH, Park KH, Park KW, Kim EJ, Oh MS, Shim Y, Lee JM, Choi YH, Park G, Kim S, Park HY, Yoon B, Yoon SJ, Cho SJ, Park KC, Na DL, Park SA, Choi SH. Cilostazol Versus Aspirin on White Matter Changes in Cerebral Small Vessel Disease: A Randomized Controlled Trial. Stroke. 2022 Mar;53(3):698-709. doi: 10.1161/STROKEAHA.121.035766. Epub 2021 Nov 16.
Han HJ, Kim BC, Youn YC, Jeong JH, Kim JH, Lee JH, Park KH, Park KW, Kim EJ, Oh MS, Shim YS, Park HY, Yoon B, Yoon SJ, Cho SJ, Park KC, Na DL, Park SA, Lee JM, Choi SH. A Comparison Study of Cilostazol and Aspirin on Changes in Volume of Cerebral Small Vessel Disease White Matter Changes: Protocol of a Multicenter, Randomized Controlled Trial. Dement Neurocogn Disord. 2019 Dec;18(4):138-148. doi: 10.12779/dnd.2019.18.4.138. Epub 2019 Dec 13.
Other Identifiers
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20130006
Identifier Type: -
Identifier Source: org_study_id
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