Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome: Prospective, Multicentre, Randomized, Open-label, Blinded-endpoint Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 32
- 主要终点
- 6MWD
研究概览
简要总结
This study is a prospective, multicentre, randomized, open-label, blinded-endpoint clinical trial to evaluate the efficacy and safety of Yangxinshi tablets in the treatment of patients with chronic coronary syndrome (CCS).
详细描述
This study plans to enrol 1200 CCS patients. A central randomized control group will be set up. The experimental and control groups will be populated at a 3:1 ratio. In addition to basic medication, the experimental group will be given Yangxinshi tablets (three tablets each time, three times a day); the control group will be given basic medication only. The treatment period is 24 weeks. The primary efficacy indicator is the 6-minute walking distance (6MWD).
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-75 years;
- •CCS patients in stable condition and clearly diagnosed by coronary artery imaging (at least one vessel stenosis ≥ 50%): stable angina, ischaemic cardiomyopathy, asymptomatic or stable symptoms, occult coronary heart disease, acute coronary syndrome (ACS), or >3 months after coronary revascularization;
- •moderately to severely limited exercise tolerance: the maximum 6MWD is < 450 m, or the metabolic equivalent (MET) as measured by treadmill cardiopulmonary exercise testing is < 5 METs;
- •voluntary participation and signing of informed consent.
排除标准
- •absolute or relative contraindications for the treadmill cardiopulmonary exercise test or 6-minute walk test (6MWT);
- •serious primary diseases, mental diseases, or malignant tumours that affect lifespan;
- •pregnancy, intended or suspected pregnancy, miscarriage, breastfeeding, or delivery in the last 6 months;
- •subjects not suitable for this study in the opinion of the researchers, such as subjects who are participating in other drug clinical trials or intervention studies.
研究组 & 干预措施
Experimental group
basic medication + Yangxinshi tablet
干预措施: Yangxinshi tablet (Drug)
Control group
basic medication.
干预措施: Basic medication (Other)
结局指标
主要结局
6MWD
时间窗: 24 weeks after treatment
The 6-min walking distance
次要结局
- Borg scale(24 weeks after treatment)
- MACCE(after 4, 8, 12, 16, 20, and 24 weeks of treatment)