NCT05730621已完成4 期
A Study to Compare the Effects of Sarpogrelate Sustained Release /Aspirin Combination Therapy Versus Aspirin on Blood Viscosity in the Patients With Peripheral Arterial Disease and Coronary Artery Disease; A Prospective, Randomized, Parallel, Open-Label, Single-center, Phase IV Clinical Trial
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2023年1月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer
研究概览
简要总结
This study is to compare the effects of sarpogrelate sustained release /aspirin combination therapy versus aspirin on blood viscosity in the patients with peripheral arterial disease and coronary artery 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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both man and woman who is over 19 years old
- •Identified as 10-75% of Stenosis in Coronary Angiography or Coronary CTA(Coronary computed tomography angiography)
- •Patients who diagnosed with peripheral artery disease or has symptoms
- •Written informed consent
排除标准
- •Patients who is scheduled surgery due to coronary artery disease or cerebral infarction disease.
- •Patients who have taken aspirin within two weeks before randomization
- •Patients who need antiplatelet or anticoagulant medication except Aspirin
- •Confirmed below results at screening
- •Hemoglobin <13g/dL
- •Platelet <60,000/µL
- •Severe kidney disease patient with eGFR(estimated Glomerular Filtration Rate) <30 mL/min/1.73 m2 (CKD-EPI)
- •Patients with a history of cerebrovascular and cardiovascular complications (brain infarction, transient cerebral ischemic seizures, myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary artery intervention) within the last six months
- •Patients with bleeding
- •Pregnant or lactating women
- •Those participating in other clinical trials for investigational products
- •Patients deemed to be ineligible to participate in the trial by investigator
研究组 & 干预措施
Sarpogrelate Sustained Release/Aspirin
Experimental
Sarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks
干预措施: Sarpogrelate Sustained Release/Aspirin (Drug)
Aspirin
Active Comparator
Aspirin Monotherapy qd for 12 weeks
干预措施: Aspirin (Drug)
结局指标
主要结局
Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer
时间窗: Baseline/Week 12
次要结局
- Change from baseline to week 4 in Blood Viscosity(cP, centipoise) measured by the blood viscometer(Baseline/Week 4)
- Change from baseline to week 4, 12 in Erythrocyte Deformability(elogation index at 3Pa) measured by Microfluidic Scanning Method(Baseline/Week 4/Week 12)
- Change from baseline to week 4, 12 in Erythrocyte Aggregation(critical shear stress) measured by Microfluidic Scanning Method(Baseline/Week 4/Week 12)
- Change from baseline to week 12 in VAS(Visual Analogue Scale)(Baseline/Week 12)
- Change from baseline to week 4, 12 in FMD(Flow Mediated Dilation) by Endothelium-dependent vasodilation measurement(Baseline/Week 4/Week 12)
- Rate of change from baseline to week 4, 12 in hs-CRP(high sensitivity C-Reactive Protein)(Baseline/Week 4/Week 12)
- Rate of change from baseline to week 4, 12 in tODI(tissue oxygen delivery index)(Baseline/Week 4/Week 12)
- Rate of change from baseline to week 4, 12 in Lipid profile(Baseline/Week 4/Week 12)
- Rate of change from baseline to week 4, 12 in HOMA-IR(Homeostatic Model Assessment for Insulin Resistance)(Baseline/Week 4/Week 12)
- Change from baseline to week 12 in SF-36(Questionnaire for Medical Outcome Short Form Health Survey, 36-Item)(Baseline/Week 12)
- Proportion of subjects who tODI(tissue oxygen delivery index) have improved by 20% or more(Week 12)
- Rate of change from baseline to week 4, 12 in FPG(Fasting Plasma Glucose)(Baseline/Week 4/Week 12)
研究者
研究点 (1)
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