Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aspirin | Active Comparator | aspirin 100mg by mouth once a day for 104 weeks |
|
| Cilostazol | Experimental | Pletaal SR 200mg by mouth once a day for 104 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin | Drug | 100mg once a day |
| |
| cilostazol |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of white matter changes (WMCs) | Measure change of WMC on brain MRI | baseline, week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging | High MD and low FA means tissue damage. | baseline and week 104 |
| Number of lacunes | High number means tissue damage. |
| Measure | Description | Time Frame |
|---|---|---|
| All ischemic stroke event | cerebral infarction and transient ischemic attack | week 104 |
| 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 |
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Seong Hye Choi, MD, PhD | Inha University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Myongji Hospital | Goyang-si | Gyeonggi-do | 412-270 | South Korea | ||
| National Health Insurance Corporation Ilsan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35833913 | Derived | 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. | |
| 34781708 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
200mg once a day |
|
|
| baseline and week 104 |
| number of microbleeds | High number means tissue damage. | baseline and week 104 |
| brain volume and cortical thickness | Low score means tissue damage. | baseline and week 104 |
| Mini-Mental State Examination | Measure global cognition. Score range is 0-30. Higher score means good cognition. | baseline, week 52, and week 104 |
| 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 |
| 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 |
| King's Health Questionnaire | Measure voiding function. Higher score means bad function. | baseline, week 42, and week 104 |
| Geriatric Depression Scale-Short form | Measure depression. Score range is 0-15. Higher score means depression. | baseline, week 52, and week 104 |
| 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 |
| 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 |
| Barthel Index | Measure physical ADL. Score range is 0-20. Higher score means good physical ADL. | baseline, week 52, and week 104 |
| 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 |
| Timed UP and Go (TUG) test | Measure gait. Higher score means bad gait. | basline, week 52, and week 104 |
| Adverse event | measure any adverse events | baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104 |
| week 104 |
| 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 | 400-711 | 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 |
| 31942173 | Derived | 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. |
| ID | Term |
|---|---|
| D059345 | Cerebral Small Vessel Diseases |
| D049292 | Leukoaraiosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided