Effects of Danlou Tablets to Prevent Left Ventricular Remodeling After Myocardial Infarction: A Double-blind, Randomized, Placebo Controlled, Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 主要终点
- change in the Left Ventricular End Diastolic Volume Index from baseline to 90 days
研究概览
简要总结
Danlou tablets are Chinese patent medicine which has been approved in China for the treatment of ischemic heart disease, but the evidence supporting its efficacy on cardiac remodeling remains unclear. This pilot study was designed to determine whether Danlou tablets reduced adverse left ventricular (LV) remodeling in patients with acute myocardial infarction (MI). Patients following acute MI were enrolled and randomly allocated to Danlou tablets (4.5 g q.d. for 90 days) or placebo, superimposed on standard medications for the treatment of MI. Major end points were changes in LV volumes and ejection fractions as evaluated by serial echocardiography in addition to clinical outcomes were also determined.
详细描述
This randomized, prospective, double-blind, placebo-controlled, parallel-group clinical trial was performed in two institutions (Guangdong Provincial Hospital of CM and Wuyi Hospital of CM). The study was conducted in accordance with the Declaration of Helsinki and its text revisions and all participants provided written informed consent before enrollment. The Clinical Research Ethical Committee at Guangdong Provincial Hospital of Chinese Medicine approved the research protocol (B2011-41-01).
Once eligible candidates had undergone PCI, they were admitted to the coronary intensive care unit and received standard treatment according to the institutional protocol based on American College of Cardiology/ American Heart Association and European Society of Cardiology guidelines.20 Simultaneously, patients were randomized assigned in a 1:1 ratio to receive Danlou tablets (4.5 g oral dose taken once daily) or matching placebo for 90 days according to a computer-generated site-stratified, block randomization schedule. Danlou tablets were approved by China Food and Drug Administration for the treatment of ischemic heart disease in 2005 (Z20050244).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute myocardial infarction
- •successfully underwent revascularization
排除标准
- •previous myocardial infarction within 30 days
- •malignant arrhythmia
- •congenital heart disease
- •cardiac shock
- •documented or suspected history of heart failure or depressed LV ejection fraction <15%
- •planned coronary artery bypass grafting
- •a life expectancy of <1 year
- •hepatic impairment
- •glomerular filtration rate ≤30 mL/min per 1.73 m2
- •autoimmune or connective tissue disease
- •chronic substance abuse or psychiatric illness
- •unable to complete 3 month clinical follow-up
研究组 & 干预措施
Danlou Tablets
Danlou tablets (4.5 g oral dose taken once daily) for 90 days
干预措施: Danlou Tablets (Drug)
placebo
matching placebo for 90 days
干预措施: Placebo (Other)
结局指标
主要结局
change in the Left Ventricular End Diastolic Volume Index from baseline to 90 days
时间窗: 90 days
Left Ventricular End Diastolic Volume Index (LVEDVi) measured by two-dimensional echocardiography.
次要结局
- changes in Left ventricular End Systolic Volume Index from baseline to 90 days(90 days)
- Major adverse cardiovascular events(90 days)
- adverse events(180 days)
- Left ventricular Ejection Fraction from baseline to 90 days(90 days)
研究者
shuai Mao
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangdong Provincial Hospital of Traditional Chinese Medicine