TRIAL OF VITAMIN E, BETA-CAROTENE & ASPRIN IN WOMEN

我们建议进行一项随机、双盲、安慰剂对照试验。 女性检测水平低(每隔一天300毫克)和非常低(每隔一天100毫克) 阿司匹林在心血管疾病一级预防中的剂量 疾病。试验的主要目的是评估治疗的效果。 阿司匹林(任一剂量)与安慰剂在联合终点的比较 所有重要血管事件(非致命性心肌梗死、非致命性 中风和总血管死亡率)。试验的次要目标是 评估使用阿司匹林(任一剂量)治疗的效果与 在完全心肌梗死的不同终点上使用安慰剂 中风和总血管死亡率，并比较两种剂量的 阿司匹林的副作用和疗效。这项试验将在 41,600名绝经后美国女护士，年龄在50岁或以上，没有 既往心血管疾病病史。邀请函和 基线问卷询问过去的病史、危险因素 心血管疾病和阿司匹林可能的禁忌症 发送给大约139万潜在参与者。护士们 愿意并有资格参加的人将被随机分配到 两种阿司匹林疗法中的任何一种，都会收到为期三个月的日历包 磨合期。磨合将排除糟糕的编译人员和那些无法 在随机化之前耐受研究药物，从而增加 试验的权力，以检测轻微到中等的影响，以及允许 对每种阿司匹林的相对短期副作用的可靠评估 剂量。在磨合期间遵守治疗方案的参与者 并保持意愿和资格的人将被重新随机分配到下列其中之一 三组，小剂量阿司匹林(300 mg隔日一次)，极小剂量阿司匹林 阿司匹林(每隔一天100毫克)，或安慰剂。为了保持高合规性， 药片将以方便的、一个月的日历包包装。每六个人 几个月，额外的日历包和问卷询问 依从性、任何副作用的发生和发展 终结点将被邮寄。终结点将通过医疗审查进行确认 由医生组成的终端委员会进行记录。这项试验将提供 全球范围内关于这些重要和及时的公众的唯一可靠数据 女性的健康问题。

We propose to conduct a randomized, double-blind, placebo-controlled trial in women testing low (300 mg/every other day) and very low (100 mg/every other day) doses of aspirin in the primary prevention of cardiovascular disease. The primary aim of the trial is to assess the effect of treatment with aspirin (either dose) compared to placebo on the combined endpoint of all important vascular events (nonfatal myocardial infarction, nonfatal stroke and total vascular mortality). Secondary aims of the trial are to evaluate the effect of treatment with aspirin (either dose) compared to placebo on the separate endpoints of total myocardial infarction, total stroke, and total vascular mortality and to compare the two doses of aspirin for side effects and efficacy. This trial will be conducted among 41,600 postmenopausal female US nurses, aged 50 years or older, with no previous history of cardiovascular disease. Letters of invitation and baseline questionnaires asking about past medical history, risk factors for cardiovascular disease and possible contraindications to aspirin will be sent to approximately 1.39 million potential participants. The nurses who are both willing and eligible to participate will be randomly assigned to either of the aspirin regimens and be sent calendar packs for a three-month run-in period. The run-in will exclude poor compliers and those unable to tolerate study medication prior to randomization and thus increase the power of the trial to detect small to moderate effects as well as allow for a reliable assessment of relative short term side effects of each aspirin dose. Participants who comply with the treatment regimen during the run-in period and who remain willing and eligible will be re-randomized to one of the three groups, low dose aspirin (300 mg every other day), very low dose aspirin (100 mg every other day), or placebo. To maintain high compliance, pills will be packaged in convenient, one-month calendar packs. Every six months, additional calendar packs and questionnaires asking about compliance, the occurrence of any side effects and the development of endpoints will be mailed. Endpoints will be confirmed by review of medical records by an endpoints committee of physicians. This trial will provide the only reliable data worldwide on these important and timely public health issues in women.