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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,700
AnHui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Medical University Of Anhui
Hefei, Anhui, China
MaAnShan Central Hospital
Maanshan, Anhui, China
Beijing An Zhen Hospital of the Capital University of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
Time frame: 24 months
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)
Time frame: 24 months
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