A Trial to Evaluate Efficacy of Heart-protecting Musk Pill
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About
Title:
A randomized, double-blind, multi-centered, placebo-controlled trial to examine effects of of Heart-protecting Musk Pill on clinical outcomes in patients with chronic stable coronary artery disease
Objective:
To examine effects of of Heart-protecting Musk Pill, a traditional Chinese medicine, on clinical outcomes in patients with chronic stable coronary artery disease
The study hypothesis:
The null hypothesis: the combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke in the treatment group is the same as that in control group.
The alternative hypothesis: the combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke in the treatment group is different from that in control group.
Sample size:
2700 patients will be randomized, 1350 in treatment group and 1350 in placebo group.
Number of sites: 99 sites in China
Study drugs:
Heart-protecting Musk Pill and the matching placebo pills.
Design:
A randomized, double-blind, multi-centered, placebo-controlled trial. Patients will be randomized to treatment group and placebo group after screening and get corresponding treatment as follow.
Treatment group: Standard treatment for coronary artery disease plus 2 Heart-protecting Musk Pills each time, three times a day by mouth for 24 months.
Control group: Standard treatment for coronary artery disease plus 2 placebo pills each time, three times a day by mouth for 24 months.
Patients will be followed up at baseline, 1, 3, 6, 9, 12, 18, 24 months after randomization. During follow-up period, patients could undertake PCI or CABG if angina get out of control or evidence of ischemia aggravated is found.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age≥18 years at screening.
- Patients who have ischemia myocardial symptoms and whose clinical symptoms keep stable for at least one month.
- Have at least one of the following events (providing hospital records or inspection report): 1)history of acute myocardial infarction for at least half of a year; 2) history of PCI or CABG for at least half of a year; 3) coronary CT angiography or coronary angiography shows that at least one of the main branches of coronary artery stenosis is no less than 50%.
- Provide informed consent form.
Exclusion criteria
- History of acute myocardial infarction, vascular reconstruction, CABG or PCI within half of a year.
- Prepared to undertake CABG or PCI during this study.
- Serious cardiovascular diseases: sustained severe angina (CCS Ⅳ), refractory heart failure, cardiogenic shock, severe aortic stenosis or aortic insufficiency.
- Severe respiratory diseases;
- Diabetic patients with poor glycemic control (fasting blood glucose > 200 mg/dl or 11.1mmol/L for more than twice within one month before the study entry).
- Hypertensive patients with poor control of blood pressure, systolic pressure≥180mmHg or diastolic pressure≥110mmHg before entry.
- Severe liver and kidney diseases,such as active liver disease, cirrhosis and uremia.
- Any other severe diseases, such as malignant tumor, severe anemia and severe renal artery stenosis.
- Unable or unwilling to sign informed consent form.
- Join another trial or has received random allocation of this study within one month before entry.
- Pregnant or who were attempting to become pregnant.
- Patients who are regarded as not being suitable participants by the study investigators.
Trial design
Primary purpose
Allocation
Interventional model
Masking
2,700 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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