A Randomized Controlled Trial of the Efficacy and Safety of Yangxinshi Tablets in the Treatment of Patients With Coronary Heart Disease Complicated by Cardiac Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,708
- 试验地点
- 96
- 主要终点
- The composite endpoint was ischemic events or heart failure-related clinical events
研究概览
简要总结
A randomized controlled trial was conducted to evaluate the efficacy and safety of Yangxinshi tablets in improving the condition of patients with coronary heart disease complicated by cardiac dysfunction.
详细描述
The purpose of this study was to investigate whether the addition of Yangxinshi tablets to conventional treatment can reduce the composite endpoint time, increase exercise tolerance, and improve quality of life and mental health in patients with coronary heart disease complicated by cardiac dysfunction. A total of 2708 eligible patients were randomly divided into two groups. In addition to conventional treatment, the trial group was given Yangxinshi tablets (3 tablets/time, 3 times/day), while the control group was a blank control. The treatment cycle continued until the expected number of endpoint events was reached or the study ended, whichever occurred first. The primary endpoint was the composite endpoint of ischemic events or heart failure-related clinical events (including all-cause death, ischemia-driven revascularization, stroke, myocardial infarction (MI), and readmission due to aggravated ACS or heart failure) during the study period.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For inpatients diagnosed with coronary heart disease (including acute coronary syndrome and chronic coronary syndrome), it is up to the doctor to decide whether to undergo revascularization and what kind of revascularization to use.
- •Patients aged between 40 and 80 years (inclusive), regardless of sex;
- •Patients with NYHA cardiac function classes II-IV;
- •Patients with NT-proBNP > 125 pg/mL (or BNP>35 pg/mL);
- •The syndrome differentiation in traditional Chinese medicine conforms to chest obstruction (qi deficiency and blood stasis syndrome)
- •Patients who voluntarily participated and signed an informed consent form.
排除标准
- •Patients with STEMI within 3 days;
- •Patients at extremely high risk of NSTEMI (hemodynamic instability, cardiogenic shock, new-onset heart failure or aggravated heart failure, severe ventricular arrhythmia)
- •Patients with acute myocardial infarction complicated with cardiogenic shock, mechanical complications, respiratory failure and other multiple organ failure;
- •Patients with severe liver dysfunction (transaminase levels more than three times the upper limit of normal), renal insufficiency (eGFR < 30mL/min/1.73m2), acute infectious diseases, and mental disorders;以上翻译结果来自有道神经网络翻译（YNMT）· 通用场景
- •Patients with drug-resistant hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
- •Pregnant or lactating women, or those planning pregnancy during the study period;
- •Patients who cannot tolerate 3 months of dual antiplatelet therapy;
- •Patients with allergic reactions or abnormal drug reactions to the study drug or any of its excipients;
- •Patients who have regularly taken Yangxinshi tablets and similar traditional Chinese medicine, Chinese patent medicine or traditional Chinese medicine decoction with the same curative effectin the past month;
- •Patients who have participated in other clinical drug trials within the last three months;
- •Patients with malignant tumors and other pathological conditions with an expected survival of less than 3 years;
- •Patients whom the investigator deems unsuitable for participating in the clinical trial.
研究组 & 干预措施
Trial group
Basic treatment and Trial drug
干预措施: Yangxinshi tablet (Drug)
Control group
Basic treatment
干预措施: Blank control (Drug)
结局指标
主要结局
The composite endpoint was ischemic events or heart failure-related clinical events
时间窗: Through study completion, an average of 3 years
All-cause death, ischemia-driven revascularization, stroke, MI, and readmission due to aggravated ACS or heart failure
次要结局
- All-cause death(Through study completion, an average of 3 years)
- Readmission due to ACS(Through study completion, an average of 3 years)
- Ischemic composite endpoint events(Through study completion, an average of 3 years)
- Heart failure-related clinical events(Through study completion, an average of 3 years)
- Cardiovascular and cerebrovascular deaths(Through study completion, an average of 3 years)
- Readmission due to aggravated heart failure(Through study completion, an average of 3 years)
- The cumulative incidence of readmission due to aggravated ACS or heart failure(Through study completion, an average of 3 years)
- Win ratio(Through study completion, an average of 3 years)
- 6MWD(From baseline at 48 weeks)
- NT-proBNP or BNP(From baseline at 48 weeks)
- Patient Health Questionnaire - 9(PHQ-9) depression scale(After 24 and 48 weeks of treatment)
- Generalized Anxiety Disorder 7 - item Scale(GAD-7) anxiety scale(After 24 and 48 weeks of treatment)
- NYHA(After 24 and 48 weeks of treatment)
- SAQ(After 24 and 48 weeks of treatment)
- KCCQ-OS(After 24 and 48 weeks of treatment)
- Echocardiography(After 48 weeks of treatment)
- Metabolic equivalents(METs)(After 48 weeks of treatment)
- Anaerobic thresholds (ATs)(After 48 weeks of treatment)
- Maximal oxygen consumption (VO2max)(After 48 weeks of treatment)
- VO2/heart rate(HR)(After 48 weeks of treatment)
- The ratio of the change in VO2 to the change in the work rate (△VO2/△WR)(After 48 weeks of treatment)