TRIAL OF VITAMIN E, BETA-CAROTENE AND ASPIRIN IN WOMEN

维生素 E、β-胡萝卜素和阿司匹林在女性中的试验

• 批准号: 2221213
• 负责人: Julie E. Buring
• 金额: $ 148.77万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-09-30 至 1996-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2221213
• 关键词: aspirin; cardiovascular disorder; cardiovascular disorder prevention; clinical trials; dosage; drug adverse effect; female; human middle age (35-64); human subject; human therapy evaluation; myocardial infarction; nurses; postmenopause; stroke; therapy compliance

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.

我们建议进行一项随机、双盲、安慰剂对照试验 在测试低（300 mg/每隔一天）和非常低（100 mg/每 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效果 与安慰剂相比，阿司匹林（任一剂量）的联合终点为 所有重要血管事件（非致死性心肌梗死，非致死性 中风和总血管死亡率）。 试验的次要目的是 评价阿司匹林（任一剂量）治疗的效果， 安慰剂对总心肌梗死、总的单独终点的影响 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。 本试验将在 41，600名绝经后女性美国护士，年龄在50岁或以上， 既往心血管疾病史。 邀请函和 基线问卷调查询问既往病史， 心血管疾病和可能的阿司匹林禁忌症将是 发送给大约139万潜在参与者。 的护士 愿意并有资格参加的人将被随机分配到 任何一种阿司匹林方案，并发送为期三个月的日历包 磨合期 这场磨合将排除那些不好的遵守者和那些无法遵守的人。 在随机化前耐受研究药物，从而增加 试验检测小至中度效应以及考虑 对每种阿司匹林的相对短期副作用的可靠评估 次给药结束 导入期间依从治疗方案的受试者 期间且仍愿意且合格的患者将重新随机分配至 三组，小剂量阿司匹林（300 mg，隔日一次），极低剂量 阿司匹林（100毫克，每隔一天），或安慰剂。 为了保持高的依从性， 药丸将被包装在方便，一个月的日历包。 每六 月，额外的日历包和问卷调查， 依从性、任何副作用的发生和 端点将被邮寄。 终点将通过审查医学 医生终点委员会的记录。 这次审判将提供 这些重要和及时公众信息的唯一可靠数据 妇女的健康问题。