NCT01932203Unknown4 期
A Multicenter, Randomized, Double Blind Study to Compare the Efficacy Between Cilostazol and Aspirin on White Matter Changes by Cerebral Small Vessel Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 255
- 试验地点
- 19
- 主要终点
- Volume of white matter changes (WMCs)
研究概览
简要总结
There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
aspirin
Active Comparator
aspirin 100mg by mouth once a day for 104 weeks
干预措施: aspirin (Drug)
Cilostazol
Experimental
Pletaal SR 200mg by mouth once a day for 104 weeks
干预措施: cilostazol (Drug)
结局指标
主要结局
Volume of white matter changes (WMCs)
时间窗: baseline, week 104
Measure change of WMC on brain MRI
次要结局
- Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging(baseline and week 104)
- Timed UP and Go (TUG) test(basline, week 52, and week 104)
- Number of lacunes(baseline and week 104)
- number of microbleeds(baseline and week 104)
- brain volume and cortical thickness(baseline and week 104)
- Mini-Mental State Examination(baseline, week 52, and week 104)
- Neurocognitive test(baseline, week 52, and week 104)
- Clinical Dementia Rating scale-sum of boxes(baseline, week 52, and week 104)
- Pyramidal and Extrapyramidal Scale (PEPS)(baseline, week 52, and week 104)
- Barthel Index(baseline, week 52, and week 104)
- King's Health Questionnaire(baseline, week 42, and week 104)
- Geriatric Depression Scale-Short form(baseline, week 52, and week 104)
- Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)(baseline, week 52, and week 104)
- Bayer Activities of Daily Living(baseline, week 52, and week 104)
- Adverse event(baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104)
研究者
Inha University Hospital
Professor
Inha University Hospital
研究点 (19)
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