The Impact of Traditional Chinese Medicine, Compound Danshen Dropping Pills (CDDP) on the Post-myocardial Infarction Ventricular Remodeling: A Multicentre, Randomized, Double-blind, Placebo-controlled, Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- ultrasonic cardiogram：left ventricular end-systolic volume index (LVESVI)
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of compound Danshen dropping pills (CDDP) in improving ventricular remodeling and cardiac function after acute anterior wall ST-Elevation myocardial infarction(STEMI). 268 patients with acute anterior wall STEMI after primary Percutaneous Coronary Intervention (pPCI) are randomly assigned 1:1 to CDDP group(n=134) and control group(n=134) with follow-up of 24 weeks. Both groups are treated with standard therapy of STEMI, with the CDDP group administrating 20 tablets of CDDP before pPCI and 10 tablets three times a day after pPCI and the control group treated with placebo at the same time. The primary endpoint is 24-week echocardiographic including left ventricle ejection fraction (LVEF) , left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI).The secondary endpoint is the change in N terminal pro-B-type natriuretic peptide（NT-proBNP ）level, arrhythmia and cardiovascular events (death, cardiac arrest or cardiopulmonary resuscitation, hospitalization due to heart failure or angina pectoris).
详细描述
Background: Progressive ventricular remodeling after acute anterior wall myocardial infarction（MI）is an important factor in the occurrence and death of heart failure. Angiotensin converting enzyme inhibitors and beta-blockers can ameliorate post-MI ventricular remodeling, but high-dose therapy can't be tolerable because of hemodynamic instability in the early stage of acute mycardial infarction（AMI）. It is known that traditional Chinese medicine, compound Danshen dropping pills (CDDP) exerts protective effect on microcirculatory disturbance caused by ischemia-reperfusion injury and improves energy metabolism after acute myocardial ischemia. Experimental studies have shown CDDP may attenuate ventricular remodeling after myocardial infarction.
Methods：This study is designed to evaluate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function after acute anterior wall ST-Elevation MI(STEMI). 268 patients with acute anterior wall STEMI after primary Percutaneous Coronary Intervention (pPCI) are randomly assigned 1:1 to CDDP group(n=134) and control group(n=134) with follow-up of 24 weeks. Both groups are treated with standard therapy of STEMI, with the CDDP group administrating 20 tablets of CDDP before pPCI and 10 tablets three times a day after pPCI and the control group treated with placebo at the same time. The primary endpoint is 24-week echocardiographic including left ventricle ejection fraction (LVEF) , left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI).The secondary endpoint is the change in N terminal pro-B-type natriuretic peptide（NT-proBNP） level, arrhythmia and cardiovascular events (death, cardiac arrest or cardiopulmonary resuscitation, hospitalization due to heart failure or angina pectoris).
Discussion：This is the first prospective study that will demonstrate the impact of CDDP on ventricular remodeling and cardiac function in patients treated with pPCI for a first acute anterior wall STEMI .This study may provide novel insights of Traditional Chinese Medicine , CDDP to improve ventricular remodeling.
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
- Double (Participant, 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
- •Aged 18-75 years, gender unlimited;
- •According to the guidelines for diagnosis and treatment of acute ST segment elevation myocardial infarction (2019), patients with acute anterior ST segment elevation myocardial infarction were diagnosed;
- •Patients with primary acute myocardial infarction;
- •Patients who completed PCI reperfusion treatment within 12 hours after the onset of the disease;
- •Patients categorized as Classes I, II or III according to Killip classification on admission;
- •Subjects participated in the study voluntarily and signed informed consent.
排除标准
- •Patients with previous cardiac insufficiency caused by other diseases (valvular heart disease, congenital heart disease, pericardial disease, arrhythmia, other non cardiac causes);
- •The patients underwent coronary artery bypass graft（CABG） within 12 weeks;
- •Patients undergoing cardiac resynchronization;
- •Patients with left ventricular outflow tract obstruction;
- •Patients with myocarditis;
- •Patients with uncontrolled severe arrhythmia;
- •Patients with aortic aneurysm;
- •Patients with serious liver, kidney, blood system, mental disease or systemic disease;
- •Significant liver and kidney dysfunction (ALT > 2.0 times the upper limit of normal value; creatinine > 1.5 times the upper limit of normal value);
- •Patients with serum potassium > 5.5mmol/l;
- •Uncontrolled hypertension (higher than 180 / 110mmhg);
- •Pregnant or lactating women;
- •Patients allergic to compound Danshen Dropping Pills; 1
- •Patients participating in clinical studies of other drugs.
研究组 & 干预措施
Experimental group
干预措施: Compound Danshen Dropping Pills (CDDP) (Drug)
Control group
干预措施: Placebo (Drug)
结局指标
主要结局
ultrasonic cardiogram：left ventricular end-systolic volume index (LVESVI)
时间窗: Week 24
LVESVI（ml/m2）=left ventricular end-systolic volume（ml）/body surface area（m2）. It can be examined by ultrasonic cardiogram.
ultrasonic cardiogram：left ventricle ejection fraction (LVEF)
时间窗: Week 24
LVEF refers to the percentage of stroke output to left ventricular end-diastolic volume and it can be examined by ultrasonic cardiogram.
ultrasonic cardiogram：left ventricular end-diastolic volume index (LVEDVI)
时间窗: Week 24
LVEDVI（ml/m2）=left ventricular end-diastolic volume（ml）/body surface area（m2）. It can be examined by ultrasonic cardiogram.
次要结局
- Adverse cardiovascular events(Day 0 to Week 48)
- N terminal pro-B-type natriuretic peptide（NT-proBNP ）decline level(Day 0/ Day 3/ Day 7/ Week 4/ Week 24/ Week 48)