A Trial to Evaluate Efficacy of Heart-protecting Musk Pill
Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
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.