NCT00741286已完成4 期
Study for the Multi-Center Placebo-Controlled Double-Blind Clinical Trial for the Evaluation of the Effect of Cilostazol on Pulsatility Index of Transcranial Doppler in the Acute Lacunar Infarction Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 8
- 主要终点
- The Changes of Middle Cerebral Artery (MCA) and Basilar Artery (BA) Pulsatility Index (PI) at 14 and 90 Days From the Baseline Transcranial Doppler (TCD) Study
研究概览
简要总结
RATIONALE:
- Elevation in pulsatility indices (PIs), measured by transcranial Doppler (TCD), has been postulated to reflect downstream increased vascular resistance caused by small-vessel disease (SVD).
- Small arterial vessels are a significant determinant of vascular resistance and PIs are elevated when SVD is present in the intracranial circulation.
- Cilostazol, a phosphodiesterase III inhibitor, has other non-antiplatelet effects, such as vasodilation and neuroprotective effect. It has been shown to be effective in the secondary prevention of stroke especially in the SVD and it may be related to the other non-antiplatelet effects of cilostazol.
OBJECTIVES:
- In this study, we aim to investigate whether cilostazol affects the changes of PIs in patients with acute lacunar infarction using serial TCDs.
- Our hypothesis is that cilostazol has other non-antiplatelet effects such as vasodilation effect and may decrease the vascular resistance in patients with acute lacunar infarction. Hence, cilostazol will decrease the PIs in patients with acute lacunar infarction.
详细描述
TREATMENTS:
- Cilostazol is an agent inhibiting platelet aggregation.
- A matching placebo of cilostazol is an inactive substance that looks similar to the active cilostazol tablet.
TREATMENT PLAN:
- There will be two treatment groups; one will receive cilostazol 200mg (100mg twice per day), the second matching placebo of cilostazol.
- These study drugs will be administered on top of aspirin (100mg) systematically prescribed to such patients
PRIMARY ENDPOINT:
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with first ever lacunar infarction within 7 days after the onset of symptoms
- •Age: more than 45 years of age
排除标准
- •Patients with any contraindications to the treatment with antiplatelet therapy
- •Patients with potential cardiac embolic source; prosthetic valve, atrial fibrillation, atrial flutter, left atrial/atrial appendage thrombus, sick sinus syndrome, left ventricular thrombus, dilated cardiomyopathy, akinetic or hypokinetic left ventricular segment, atrial myxoma, Infective endocarditis, mitral valve stenosis or prolapse, mitral annuls calcification, left atrial turbulence, nonbacterial endocarditis, congestive heart failure, recent myocardial infarction (within 4 weeks)
- •Bleeding diathesis
- •Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine > 3.0mg/dl)
- •Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
- •Nonatherosclerotic vasculopathy; patients with clinical characteristics suggesting arterial dissection, moyamoya disease, Takayasu's arteritis, radiation associated angiopathy, and other vasculitis.
- •Pregnant or lactating patients
- •Patients with hyperthyroidism or COPD
- •Patients with current anticoagulation or antiplatelet therapy
- •Patients with poor temporal window in transcranial Doppler
研究组 & 干预措施
Asprin (100mg) plus placebo
Placebo Comparator
Asprin (100mg) plus placebo
干预措施: Aspirin (Drug)
Asprin (100mg) plus cilostazol (200mg)
Active Comparator
Asprin (100mg) plus cilostazol (200mg)
干预措施: cilostazol (Drug)
结局指标
主要结局
The Changes of Middle Cerebral Artery (MCA) and Basilar Artery (BA) Pulsatility Index (PI) at 14 and 90 Days From the Baseline Transcranial Doppler (TCD) Study
时间窗: 14 days and 90 days from the baseline TCD study
The PI is designed to measure vascular resistance and characterizes the shape of the spectral waveform. For the study, the mean, systolic, and diastolic flow velocities were measured using TCD. Gosling's PI was determined as the difference between the peak systolic and end-diastolic velocities divided by the mean flow velocity in each artery.The changes of MCA and BA PIs at 14 and 90 days from the baseline TCD study was calculated for the study.
次要结局
- Number of Patients With First Recurrent Stroke of Any Type(90 days)
研究者
研究点 (8)
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