[China coronary secondary prevention study (CCSPS)]

Abstract

Objective: The mean level of serum cholesterol in Chinese population with coronary heart disease (CHD) is relatively lower compared to that of western population. Our study aimed to evaluate whether lipid-lowering therapy with Xuezhikang can reduce the risk of cardiac events and total mortality in Chinese CHD patients.

Methods: This study was designed as a random, double-blinded, placebo controlled clinical trial in 66 centers in China and was conducted from may, 1996 to December, 2003. 4870 CHD patients (serum cholesterol level 4.40 - 6.47 mmol/L, age 18 - 75 years, with definite myocardial infarction history) were selected and treated with capsule Xuezhikang (0.6 g Bid) or placebo in addition to conventional therapy (control group). The mean follow-up period was four years. The primary end-points were nonfatal myocardial infarction and deaths from CHD.

Results: It has been shown at the end of the trial: (1) The incidence of the primary end-points were 5.72% in Xuezhikang treatment group and 10.41% in control group, with a reduction of relative risk by 45.1% for treatment group (P = 0.0000). Among the primary end points, the incidence of deaths from CHD was 3.79% in the treatment group and 5.49% in the control group, with a reduction of relative risk by 31.0% in treatment group (P < 0.0048); (2) The incidence of nonfatal myocardial infarction reduced by 60.8% in treatment group compared to control group (1.93% vs 4.92%, P < 0.0000); (3) The incidence of the secondary end-points (stroke, tumor, PCI/CABG) also decreased by 31.1% in treatment group compared to control group (6.92% vs 10.04% P < 0.0004). Among the secondary end points, the demand for PCI/CABG was 3.01% in the treatment group and 4.51% in the control group, with a reduction of relative risk by 33.3% in treatment group (P = 0.097); (4) The total mortality was lower in treatment group than control group, with a reduction of relative risk by 33.0% in treatment group (5.19% vs 7.74% P = 0.0003). There were no significant differences in side effects and abnormal laboratory references between the two groups.

Conclusions: Compared to placebo, Xuezhikang can significantly decrease the incidence of nonfatal myocardial infarction and deaths from CHD. It can also reduce significantly the demand for PCI/CABG, the total mortality and the deaths from tumor.