Curative Effect Evaluation of Danlou Tablet on Coronary Artery Disease Not Amenable to Revascularization
Phase 4
- Conditions
- Coronary Artery Disease(CAD)
- Interventions
- Registration Number
- NCT03072082
- Lead Sponsor
- Jun Li
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 440
Inclusion Criteria
- 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".
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Danlou Tablet Aspirin Enteric-coated Tablets 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) Danlou Tablet placebo Atorvastatin calcium 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) Danlou Tablet placebo Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet 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) Danlou Tablet Trimetazidine Dihydrochloride Tablets 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) Danlou Tablet placebo Metoprolol Tartrate Tab 25 MG 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) Danlou Tablet placebo Trimetazidine Dihydrochloride Tablets 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) Danlou Tablet Clopidogrel Hydrogen Sulfate 75 MG Oral 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) Danlou Tablet placebo 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) Danlou Tablet placebo Isosorbide Mononitrate Tab 20 MG 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) Danlou Tablet placebo Aspirin Enteric-coated Tablets 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) Danlou Tablet Isosorbide Mononitrate Tab 20 MG 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) Danlou Tablet 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) Danlou Tablet Atorvastatin calcium 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) Danlou Tablet Metoprolol Tartrate Tab 25 MG 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)
- Primary Outcome Measures
Name Time Method Mortality Six months after randomisation Death caused by cardiovascular disease
- Secondary Outcome Measures
Name Time Method E/A ratio At baseline (before randomisation), and six months after randomisation One of Echocardiographic parameters
C-reactive protein (CRP) At baseline (before randomisation), and six months after randomisation. CRP in μg/L
B-type natriuretic peptide (BNP) At baseline (before randomisation), and six months after randomisation. BNP in pg/mL
Ejection fraction percentage (EF%) At baseline (before randomisation), and six months after randomisation One of Echocardiographic parameters
Hospital readmission rates At baseline (before randomisation), and six months after randomisation. Hospital readmission rates due to coronary artery disease during treatment