An Open Label, Single Arm, Multiple Center Study Observing the Efficacy of Dun Ye Guan Xin Ning Tablet in Patients With Coronary Artery Disease of Angina Pectoris
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Angina pectoris symptom
研究概览
简要总结
This registry is designed to investigate factors affecting the efficacy of Dun Ye Guan Xin Ning tablet on patients with stable angina. The potential hypothesis is that Dun Ye Guan Xin Ning has a better effect on different subgroup patients with certain characteristics.
详细描述
A total of 1000 eligible patients enrolled from 20 centers will take standard medications of care for stable angina plus Dun Ye Guan Xin Ning tablet for 6 months. Symptoms, questionnaires (SAQ, PSQI, and angina pectoris quantitative table of Chinese medicine symptoms scale), lipid, fasting glucose, homocysteine, EKG, blood pressure and other physical examination will be collected at baseline and follow-up. Among them, 200 patients will measure and inflammation biomarkers and endothelial function for further evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Aged between 18 and 75 years.
- •Documented stable angina pectoris.
- •During a period of time (more than 3 months), the duration, severity and the threshold of angina is relatively stable.
- •Patients with at least one of the following events: ① patients who have done PCI or CABG for more than half a year; ② coronary CTA angiography or coronary angiography showed at least one major coronary artery stenosis ≥ 50%. Symptom occurs at least once per month.
- •Medications remain stable within 1 month before the enrollment.
- •Patients have the ability to understand the study, and can cooperate with researchers to carry out the test.
- •Signed inform consent.
排除标准
- •Patents with coronary heart disease acute coronary syndrome during the last 6 months.
- •Patients with aortic stenosis, hypertrophic cardiomyopathy and other diseases leading to angina.
- •Patients have other heart disease, severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, biliary heart disease, gastroesophageal reflux caused by chest pain.
- •Patients combined with severe cardiopulmonary insufficiency (NYHA grade III ord IV), pulmonary insufficiency graded reference COPD clinical severity of lung function grade III (FEV1 / FVC <70%, 30% 1 / FVC% of predicted value <50%) and grade IV), severe arrhythmia (eg. III degree atrioventricular block)
- •Patients combined with liver, kidney, hematopoietic system and other serious primary disease patients (TBil ≥ 1.5ULN, AST ≥ 2ULN, ALT ≥ 2ULN, serum creatinine ≥ 1.5ULN, Hb <9mg/dL).
- •Patients with cognitive, intellectual, or mental disorders.
- •Those who can not take oral medication.
- •Allergy to any component of this product.
- •Patients received the trial medication within 28 days prior to the first treatment of this product.
- •Lactating or pregnant women.
- •Patients who are unwilling or unable to contraceptive in the reproductive period.
- •Poor medication compliance.
- •Other circumstances that the investigator considers unsuitable for inclusion.
研究组 & 干预措施
Dun Ye Guan Xin Ning mono-therapy
干预措施: Dun Ye Guan Xin Ning (Drug)
结局指标
主要结局
Angina pectoris symptom
时间窗: 6 month
Improvement od angina pectoris symptom
次要结局
- Life quality(6 month)
- Sleep quality(6 month)
- Biomarkers(6 month)
- Chest tightness(0, 1 month, 3 month, 6 month)
研究者
Yong Huo
Director of the Department of Cardiology and heart center of Peking University First Hospital
Peking University First Hospital