Study design of ASPirin in Reducing Events in the Elderly (ASPREE): a randomized, controlled trial.
Study design of ASPirin in Reducing Events in the Elderly (ASPREE): a randomized, controlled trial.
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DOI：
10.1016/j.cct.2013.09.014
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发表时间：
2013-11
影响因子：
2.2
通讯作者：
ASPREE Investigator Group
中科院分区：
文献类型：
--
作者：
ASPREE Investigator Group
需要采取具有成本效益的战略，在老龄化人口中保持健康积极的生活方式，以应对与年龄有关的疾病的全球负担。ASPREE将检查低剂量阿司匹林的潜在一级预防益处是否超过老年健康个体的风险。我们的主要假设是，每日口服100 mg肠溶阿司匹林将延长复合主要终点（称为“无残疾生活”），包括19，000名年龄在65岁及以上（“美国少数民族”）和70岁及以上（非“美国少数民族"）的健康受试者中至少一项Katz日常生活活动的痴呆发作、总死亡率或持续残疾。ASPREE是一项双盲、随机、安慰剂对照试验，在澳大利亚和美国社区环境中对无痴呆、残疾和心血管疾病（CVD）事件的个体进行口服100 mg肠溶乙酰水杨酸（阿萨）或匹配安慰剂。次要终点是全因和原因特异性死亡率、致死性和非致死性心血管事件、致死性和非致死性癌症（不包括非黑色素瘤皮肤癌）、痴呆、轻度认知障碍、抑郁、身体残疾和临床显著出血。截至2013年9月20日，已招募14，383名参与者。预计招募和研究分别于2014年7月和2018年12月完成。与其他主要关注心血管终点的阿司匹林试验相比，ASPREE具有独特的复合主要终点，可以更好地捕获阿司匹林延长美国和澳大利亚老年人健康独立寿命的总体风险和获益。
Cost-effective strategies to maintain healthy active lifestyle in aging populations are required to address the global burden of age-related diseases. ASPREE will examine whether the potential primary prevention benefits of low dose aspirin outweigh the risks in older healthy individuals. Our primary hypothesis is that daily oral 100 mg enteric-coated aspirin will extend a composite primary endpoint termed ‘disability-free life’ including onset of dementia, total mortality, or persistent disability in at least one of the Katz Activities of Daily Living in 19,000 healthy participants aged 65 years and above (‘US minorities’) and 70 years and above (non ‘US minorities’). ASPREE is a double-blind, randomized, placebo-controlled trial of oral 100 mg enteric-coated acetyl salicylic acid (ASA) or matching placebo being conducted in Australian and US community settings on individuals free of dementia, disability and cardiovascular disease (CVD) events. Secondary endpoints are all-cause and cause specific mortality, fatal and non-fatal cardiovascular events, fatal and non-fatal cancer (excluding non-melanoma skin cancer), dementia, mild cognitive impairment, depression, physical disability, and clinically significant bleeding. To 20 September 2013 14383 participants have been recruited. Recruitment and study completion is anticipated in July 2014 and December 2018 respectively. In contrast to other aspirin trials that have largely focused on cardiovascular endpoints, ASPREE has a unique composite primary endpoint to better capture the overall risk and benefit of aspirin to extend healthy independent lifespan in older adults in the US and Australia.
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影响因子：
3.4
作者：
KATZ, S;AKPOM, CA
通讯作者：
AKPOM, CA
影响因子：
105.7
作者：
PETO, R;GRAY, R;DOLL, R
通讯作者：
DOLL, R
影响因子：
--
作者：
Reid, W;Broe, G;Sulway, MR
通讯作者：
Sulway, MR
影响因子：
168.9
作者：
Hansson, L;Zanchetti, A;Westerling, S
通讯作者：
Westerling, S
影响因子：
158.5
作者：
HENNEKENS, CH
通讯作者：
HENNEKENS, CH