NCT05083299已完成不适用
Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate on Symptom Improvement in Patients With Peripheral Arterial Disease
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 1,003 人开始时间: 2020年1月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,003
- 试验地点
- 1
- 主要终点
- Change in Peripheral Artery Questionnaire
研究概览
简要总结
The study will evaluate the effect of Anpl-one SR Tablet on the improvement of symptoms in daily care environments using PAQ.
详细描述
The purpose of this study is to evaluate the effect of Anple-one SR Tablet on the improvement of symptoms in daily care environments within the scope of 300 milligrams of Anpl-one SR Tablet (sarpogrelate hydrochloride agent) using PAQ.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 19 and under 80 years of age.
- •Patients who first administered Sarpogrelate hydrochloride drugs or less than 3 months to improve ischemic symptoms such as ulcers, pain, and coldness caused by chronic arterial obstruction (Burger's disease, obstructive arteriosclerosis, diabetic peripheral angiopathy, etc.).
- •Patient who voluntarily signed a written consent form approved by the Clinical Trial Review Committee or Ethics Committee and agreed to participate in the study by the patient or the subject's agent.
排除标准
- •Patient who is expected to have less than two years of life expectancy.
- •Patient who have bleeding within a week of participation in the study
- •Patient suffering from diseases that may increase bleeding during study participation (hemophilia, capillary placebo, digestive tube ulcer, urinary tract bleeding, hemoptysis, hyperself-bleeding, etc.).
- •A female patient who is likely to be pregnant or pregnant.
- •Female patients who are lactating or are scheduled to be lactated at the time of participation in the study.
- •Patients with severe renal disease and liver disease.
研究组 & 干预措施
Anpl-one SR Tablet
Patients who prescribed Anpl-one SR Tablet
干预措施: Sarpogrelate (Drug)
结局指标
主要结局
Change in Peripheral Artery Questionnaire
时间窗: 24 weeks
Change in Peripheral Artery Questionnaire at 24 weeks compared to baseline
次要结局
- Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients(24 weeks)
- Peripheral Artery Questionnaire change(24 weeks)
- Change in each domain of Peripheral Artery Questionnaire(24 weeks)
研究者
研究点 (1)
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