Coronary Artery Disease(CAD)
Conditions
Keywords
coronary artery disease, revascularization, Danlou Tablet
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.
Interventions
DRUGDanlou Tablet
Conventional western medicine & Danlou Tablet
DRUGDanLou Tablet placebo
Conventional western medicine & placebo (for Danlou Tablet)
100 mg tablet, one tablet daily.
One tablet daily. (for patients who can't use aspirin)
DRUGAtorvastatin calcium
10 mg tablet, two tablets each night.
One tablet two times daily.
12.5 mg or 25 mg two times daily.
20 mg tablet, one tablet three times daily.
Sponsors
China Academy of Chinese Medical Sciences
Jun Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Six months after randomisation | Death caused by cardiovascular disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital readmission rates | At baseline (before randomisation), and six months after randomisation. | Hospital readmission rates due to coronary artery disease during treatment |
| Ejection fraction percentage (EF%) | At baseline (before randomisation), and six months after randomisation | One of Echocardiographic parameters |
| 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 |
Contacts
Primary ContactJun Li, MD
Backup ContactPanpan Tian
Outcome results
None listed