NCT03509922已完成4 期
A Randomized, Dose-controlled, Open-label, Parallel, 2-treatment Group, Single Center, Pilot Study to Evaluate the Effectiveness of Sarpogrelate on Blood Hyperviscosity in the Patients With Peripheral Arterial Disease
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline to week 24 in tissue oxygen delivery index (tODI)
研究概览
简要总结
This study is to evaluate the effect of sarpogrelate on blood viscosity after 24 weeks in patients with high blood viscosity.
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
- •Patients diagnosed with PAD* (*Criteria for diagnosis of PAD: diagnosed with Burger's disease, obstructive arteriosclerosis, diabetic peripheral vascular disease, or with ischemic symptoms such as ulcers, pain, cold sensation, etc.)
- •tODI < 3 at randomization
- •Aged ≥ 19 years
- •Written informed consent
排除标准
- •Patients requiring acute or two or more antiplatelet agents
- •Patients requiring anticoagulant therapy
- •Patients requiring surgical procedure due to vascular occlusion
- •Patients whose results are confirmed at the screening as follows:
- •hemoglobin (Hb) test value: male < 13 g/dL, female < 12 g/dL
- •platelet count < 60,000/µL
- •severe renal disease (eGFR < 30 mL/min/1.73 m2)
- •Patients with a history of cerebrovascular and cardiovascular complications (cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass, percutaneous coronary intervention) within the last 6 months
- •Contraindications stated in the SPC of sarpogrelate
- •Patients who are pregnant or planning to become pregnant
- •Those participating in other clinical trials with administration of investigational products at the screening
- •Those who are deemed to be ineligible to participate in the trial by investigator
研究组 & 干预措施
Anplag Tab. 100mg bid
Experimental
sarpogrelate hydrochloride 100mg bid for 24 weeks
干预措施: Anplag Tab. 100mg bid (Drug)
Anplag Tab. 100mg tid
Experimental
sarpogrelate hydrochloride 100mg tid for 24 weeks
干预措施: Anplag Tab. 100mg tid (Drug)
结局指标
主要结局
Change from baseline to week 24 in tissue oxygen delivery index (tODI)
时间窗: baseline, week 24
次要结局
- Proportion of subjects with tODI elevated by 20% or more(baseline, week 12, week 24)
- Change from baseline to week 24 in 36-Item Short Form Health Survey (SF-36)(baseline, week 24)
- Change from baseline to week 12 in tODI(baseline, week 12)
研究者
研究点 (1)
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