Study of Curative Effect Evaluation of DanLou Tablet on Coronary Artery Disease Not Amenable to Revascularization on the Basis of Western Medicine Therapy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 440
- 主要终点
- Mortality
研究概览
简要总结
The purpose of this study is to determine whether Danlou Tablet is effective in the treatment of coronary artery disease not amenable to revascularization on the basis of western medicine therapy.
详细描述
The western medicine treatment for CAD not amenable to revascularization is limited. Danlou Tablet, a kind of Chinese patent medicine has been used for treating coronary artery disease in clinical practice in China for many years.
Danlou Tablet is applicable to "phlegm-stasis syndrome" in Traditional Chinese Medicine. According to recent studies, Danlou Tablet can reduce blood lipid level and myocardial necrosis area ,promote infarct healing in rats.And it can improve clinical symptoms of patients with CAD.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are aged between 45 and 75 years, diagnosed with sever CAD through coronary arteriography which shows that the left main coronary artery and three-vessel have sever diffuse stenosis, calcification or vascular ectasia, be in accordance with Traditional Chinese Medicine syndrome of "Qi deficiency and blood stasis syndrome" or "phlegm and stasis mu-tual obstruction syndrome".
排除标准
- •Patients with severe valvular disease, congenital cardiomyopathy decompensation
- •Patients with CAD complicated with severe multiple organ disease such as severe heart failure, severe lung, liver or renal dysfunction, peptic ulcer in active stage, or intracranial hemorrhage
- •Patients that use high-dose steroids due to connective tissue disease
- •Patients with serious infections
- •Patients with malignant tumor
- •Patients with hematopoietic diseases
- •Pregnant or lactating women.
研究组 & 干预措施
Danlou Tablet
Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months & conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Danlou Tablet (Drug)
Danlou Tablet
Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months & conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Aspirin Enteric-coated Tablets (Drug)
Danlou Tablet
Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months & conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet (Drug)
Danlou Tablet
Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months & conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Atorvastatin calcium (Drug)
Danlou Tablet
Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months & conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Isosorbide Mononitrate Tab 20 MG (Drug)
Danlou Tablet
Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months & conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Metoprolol Tartrate Tab 25 MG (Drug)
Danlou Tablet
Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months & conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Trimetazidine Dihydrochloride Tablets (Drug)
Danlou Tablet placebo
Placebo Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months & conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: DanLou Tablet placebo (Drug)
Danlou Tablet placebo
Placebo Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months & conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Aspirin Enteric-coated Tablets (Drug)
Danlou Tablet placebo
Placebo Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months & conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet (Drug)
Danlou Tablet placebo
Placebo Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months & conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Atorvastatin calcium (Drug)
Danlou Tablet placebo
Placebo Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months & conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Isosorbide Mononitrate Tab 20 MG (Drug)
Danlou Tablet placebo
Placebo Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months & conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Metoprolol Tartrate Tab 25 MG (Drug)
Danlou Tablet placebo
Placebo Danlou 0.3g tablet by mouth, 5 tablets three times daily for 6 months & conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Trimetazidine Dihydrochloride Tablets (Drug)
结局指标
主要结局
Mortality
时间窗: Six months after randomisation
Death caused by cardiovascular disease
次要结局
- C-reactive protein (CRP)(At baseline (before randomisation), and six months after randomisation.)
- E/A ratio(At baseline (before randomisation), and six months after randomisation)
- B-type natriuretic peptide (BNP)(At baseline (before randomisation), and six months after randomisation.)
- Ejection fraction percentage (EF%)(At baseline (before randomisation), and six months after randomisation)
- Hospital readmission rates(At baseline (before randomisation), and six months after randomisation.)
研究者
Jun Li
Director of Cardiology
Guang'anmen Hospital of China Academy of Chinese Medical Sciences