A Randomized, Double-blind, Multi-centered, Placebo-controlled Trial to Examine Effects of Heart-protecting Musk Pill on Clinical Outcome in Patients With Chronic Stable Coronary Artery Disease
Overview
- Phase
- Phase 4
- Intervention
- Heart-protecting Musk Pill
- Conditions
- Coronary Artery Disease
- Sponsor
- Shanghai Hutchison Pharmaceuticals Limited
- Enrollment
- 2700
- Locations
- 98
- Primary Endpoint
- The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Heart-protecting Musk Pill
Patients will get standard treatment for coronary artery disease plus 2 Heart-protecting Musk Pills each time, three times a day by mouth for 24 months
Intervention: Heart-protecting Musk Pill
Placebo
Patients will get standard treatment for coronary artery disease plus 2 placebo pills each time, three times a day by mouth for 24 months
Intervention: Placebo
Outcomes
Primary Outcomes
The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
Time Frame: 24 months
Secondary Outcomes
- The combined incidence of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina or heart failure, and peripheral revascularization (PCI or CABG)(24 months)