J Clin Epidemiol. 1992 Aug;45(8):849-60. doi: 10.1016/0895-4356(92)90068-x.
This paper describes the design of the West of Scotland Coronary Prevention Study (WOSCOPS) which is a primary prevention trial involving men aged 45-64 yr with raised plasma cholesterol levels. The principal aim is to test the hypothesis that reduction of serum cholesterol by treatment with pravastatin [a competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase--a regulatory enzyme in cholesterol synthesis] over an average period of 5 yr will lead to a reduction in fatal and non-fatal myocardial infarction. A trial population of approx. 6500 men have been randomized in equal numbers to treatment with placebo or pravastatin. At the time of randomization, these men have no evidence of previous myocardial infarction. All subjects are given smoking and dietary advice throughout the study. The principal endpoints are: (i) coronary heart disease death plus non-fatal myocardial infarction, (ii) coronary heart disease death, and (iii) non-fatal myocardial infarction.
本文描述了苏格兰西部冠心病预防研究（WOSCOPS）的设计，这是一项针对血浆胆固醇水平升高的45至64岁男性的一级预防试验。主要目的是检验这样一个假设：在平均5年的时间里，用普伐他汀[一种3-羟基-3-甲基戊二酰辅酶A（HMG CoA）还原酶的竞争性抑制剂——胆固醇合成中的一种调节酶]治疗降低血清胆固醇，将导致致命和非致命性心肌梗死的减少。大约6500名男性的试验人群已被等数随机分为接受安慰剂或普伐他汀治疗。在随机分组时，这些男性没有既往心肌梗死的证据。在整个研究过程中，所有受试者都得到了吸烟和饮食方面的建议。主要终点为：（i）冠心病死亡加非致命性心肌梗死，（ii）冠心病死亡，以及（iii）非致命性心肌梗死。
