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

Wolfe, R, Murray, AM, Woods, RL, Kirpach, B, Gilbertson, D, Shah, RC, Nelson, MR ORCID: 0000-0001-9941-7161, Reid, CM, Ernst, ME, Lockery, J, Donnan, GA, Williamson, J and McNeil, JJ 2018 , 'The aspirin in reducing events in the elderly trial: Statistical analysis plan' , International Journal of Stroke, vol. 13, no. 3 , pp. 335-338 , doi: 10.1177/1747493017741383.

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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.

Item Type: Article
Authors/Creators:Wolfe, R and Murray, AM and Woods, RL and Kirpach, B and Gilbertson, D and Shah, RC and Nelson, MR and Reid, CM and Ernst, ME and Lockery, J and Donnan, GA and Williamson, J and McNeil, JJ
Keywords: aspirin, clinical trial, disability free survival, intracerebral hemorrhage, ischemic stroke, protocols, statistical analysis plan
Journal or Publication Title: International Journal of Stroke
Publisher: Sage Publications Ltd.
ISSN: 1747-4930
DOI / ID Number: 10.1177/1747493017741383
Copyright Information:

Copyright 2017 World Stroke Organization

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