Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease (Challenge)
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|ClinicalTrials.gov Identifier: NCT01932203|
Recruitment Status : Active, not recruiting
First Posted : August 30, 2013
Last Update Posted : August 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Small Vessel Disease||Drug: aspirin Drug: cilostazol||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||255 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||July 17, 2013|
|Actual Primary Completion Date :||August 6, 2019|
|Estimated Study Completion Date :||August 31, 2019|
Active Comparator: aspirin
aspirin 100mg by mouth once a day for 104 weeks
100mg once a day
Pletaal SR 200mg by mouth once a day for 104 weeks
200mg once a day
Other Name: Pletaal SR
- Volume of white matter changes (WMCs) [ Time Frame: baseline, week 104 ]Measure change of WMC on brain MRI
- Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging [ Time Frame: baseline and week 104 ]High MD and low FA means tissue damage.
- Number of lacunes [ Time Frame: baseline and week 104 ]High number means tissue damage.
- number of microbleeds [ Time Frame: baseline and week 104 ]High number means tissue damage.
- brain volume and cortical thickness [ Time Frame: baseline and week 104 ]Low score means tissue damage.
- Mini-Mental State Examination [ Time Frame: baseline, week 52, and week 104 ]Measure global cognition. Score range is 0-30. Higher score means good cognition.
- Neurocognitive test [ Time Frame: 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 [ Time Frame: baseline, week 52, and week 104 ]Measure global cognition. Score range is 0-18. Higher score means good cognition.
- King's Health Questionnaire [ Time Frame: baseline, week 42, and week 104 ]Measure voiding function. Higher score means bad function.
- Geriatric Depression Scale-Short form [ Time Frame: baseline, week 52, and week 104 ]Measure depression. Score range is 0-15. Higher score means depression.
- Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) [ Time Frame: 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 [ Time Frame: baseline, week 52, and week 104 ]Measure instrumental activities of daily living (ADL). Score range is 1-10. Higher score means bad ADL.
- Barthel Index [ Time Frame: baseline, week 52, and week 104 ]Measure physical ADL. Score range is 0-20. Higher score means good physical ADL.
- Pyramidal and Extrapyramidal Scale (PEPS) [ Time Frame: baseline, week 52, and week 104 ]Measure neurologic signs. Score range is 0-60. Higher score means many abnormal neurologic signs.
- Timed UP and Go (TUG) test [ Time Frame: basline, week 52, and week 104 ]Measure gait. Higher score means bad gait.
- Adverse event [ Time Frame: baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104 ]measure any adverse events
- All ischemic stroke event [ Time Frame: week 104 ]cerebral infarction and transient ischemic attack
- All vascular events [ Time Frame: week 104 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932203
|Principal Investigator:||Seong Hye Choi, MD, PhD||Inha University Hospital|