Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI: a Prospective，Muhicenter,Doubleblind, Double-dummy, Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 681
- 试验地点
- 15
- 主要终点
- Change in METs assessed by the CPET
研究概览
简要总结
This study compared the effect of Yangxinshi on exercise tolerance of patients with percutaneous coronary intervention (PCI) for the first time with Trimetazidine.Half of participants will receive Yangxinshi and Trimetazidine mimic tablets in combination,While the other half will receive Trimetazidine and Yangxinshi mimic tablets.
详细描述
The Primary Purpose of this study is to compare the effect of Yangxinshi on exercise tolerance of patients with percutaneous coronary intervention (PCI) for the first time with Trimetazidine, The target patients are the people who underwent PCI for the first time and can be carried on Cardiopulmonary exercise test. The treatment period was 24 weeks. The patients were randomly divided into two groups.： A: Yangxinshi pill 3 pills /tid and Trimetazidine mimic tablets 20mg/tid B: Trimetazidine mimic tablets 20mg/tid and Yangxinshi pill 3 pills /tid The patients were followed up for 0 weeks, 4 weeks, 12 weeks, 24 weeks and 28 weeks after entering the group.
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
- 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, gender is not limited；
- •The patient within two month after PCI operation for the first time；
- •The patient had 1-2 coronary artery lesions with complete revascularization：At least one drug eluting stent was implanted，and residual coronary artery stenosis after PCI <30%；
- •Have not revascularization plan within 6 months；
- •After being evaluated by clinicians on aerobic exercise ability，patients can carry out early rehabilitation in hospital and exercise cardiopulmonary rehabilitation outside the hospital；
- •Coronary heart disease patients with Qi Deficiency and Blood Stasis Syndrome；
- •Participants voluntarily participated in and signed informed consent；
排除标准
- •Patients was diagnosed with AMI as the first diagnosis in the past month, and then hospitalized for PCI operation；
- •Patients with absolute and relative contraindications in cardiopulmonary exercise test；
- •Any drug allergy to Yangxinshi pill and trimetazidine；
- •Patients have taken regular Yangxinshi pill, trimetazidine or other Chinese patent medicine regularly in the past month；
- •Patients are intolerant of aspirin, clopidogrel, statins, beta blockers or ACEI drugs (such as massive hemorrhage, severe hypotension, etc.)；
- •History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months
- •Active bleeding disease within 6 months；
- •Combined with severe liver and kidney dysfunction (creatinine clearance ≤ 30ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 3 × upper limit of clinical reference), other lifethreatening serious primary or psychiatric diseases and malignant tumors
- •Hemoglobin <90 g/L；
- •Cardiac function (NYHA) grade IV or echocardiography LVEF < 30%；
- •Venous blood pressure <100/60 mmHg；
- •In past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth
- •The expected survival period is less than one year.；
- •Patients who are participating in other clinical studies.
研究组 & 干预措施
Trimetazidine
干预措施: Yangxinshi mimic (Drug)
Yangxinshi
干预措施: Yangxinshi (Drug)
Yangxinshi
干预措施: Trimetazidine mimic (Drug)
Trimetazidine
干预措施: Trimetazidine (Drug)
结局指标
主要结局
Change in METs assessed by the CPET
时间窗: 24 weeks
MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test
次要结局
- Changes of anaerobic threshold (AT) by CPET(24 weeks)
- Incidence of major cardiovascular events (MACE)(4,12,24 and 28 weeks)
- PHQ-9 Depression Scale(24 weeks)
- Changes of Seattle Angina Questionnaire(24 weeks)
- Frequency of angina pectoris(24 weeks)
- The proportion of METs>7 patients(24 weeks)
- Changes of VO2max by CPET(24 weeks)
- Changes of VO2/HR by CPET(24 weeks)
- Changes of VO2/W by CPET(24 weeks)
- GAD-7 Anxiety Screening Scale(24 weeks)
研究者
Han Yaling
Director, clinical professor
Shenyang Northern Hospital