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    The aspirin in reducing events in the elderly trial: Statistical analysis plan

    Access Status
    Fulltext not available
    Authors
    Wolfe, R.
    Murray, A.
    Woods, R.
    Kirpach, B.
    Gilbertson, D.
    Shah, R.
    Nelson, M.
    Reid, Christopher
    Ernst, M.
    Lockery, J.
    Donnan, G.
    Williamson, J.
    McNeil, J.
    Date
    2018
    Type
    Journal Article
    
    Metadata
    Show full item record
    Citation
    Wolfe, R. and Murray, A. and Woods, R. and Kirpach, B. and Gilbertson, D. and Shah, R. and Nelson, M. et al. 2018. The aspirin in reducing events in the elderly trial: Statistical analysis plan. International Journal of Stroke. 13 (3): pp. 335-338.
    Source Title
    International Journal of Stroke
    DOI
    10.1177/1747493017741383
    ISSN
    1747-4930
    School
    School of Public Health
    URI
    http://hdl.handle.net/20.500.11937/67682
    Collection
    • Curtin Research Publications
    Abstract

    Rationale: Aspirin has positive and negative effects on a number of age-related chronic conditions and there is uncertainty regarding its role in primary prevention in people aged 70 years and over. Aims: To assess whether daily active treatment of 100 mg enteric-coated aspirin will extend the duration of disability-free life in healthy older participants. Design: A double-blind, randomized, placebo-controlled primary prevention trial undertaken in Australia and the United States with careful adjudication of endpoints including stroke. Study outcome: In Australia 16,703 individuals were recruited through general practices across five states and territories, and in the United States, 2411 participants were recruited through 34 clinical sites across the country. Follow-up of participants will finish at the end of 2017 with average follow-up exceeding 4.25 years per person. Discussion: The statistical analysis plan for ASPREE, finalized after closure of recruitment but before the end of patient follow-up, outlines the primary analyses and a range of subgroup and sensitivity analyses. (International Standard Randomized Controlled Trial Number Register ISRCTN83772183 and clinicaltrials.gov Number NCT01038583).

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