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, The aspirin in reducing events in the elderly trial: statistical analysis plan, International Journal of Stroke, 13, (3) pp. 335-338. ISSN 1747-4930 (2018) [Contribution to Refereed Journal]
Copyright 2017 World Stroke Organization
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:||Contribution to Refereed Journal|
|Keywords:||aspirin, clinical trial, disability free survival, intracerebral hemorrhage, ischemic stroke, protocols, statistical analysis plan|
|Research Division:||Biomedical and Clinical Sciences|
|Research Group:||Cardiovascular medicine and haematology|
|Research Field:||Cardiology (incl. cardiovascular diseases)|
|Objective Group:||Clinical health|
|Objective Field:||Clinical health not elsewhere classified|
|UTAS Author:||Nelson, MR (Professor Mark Nelson)|
|Web of Science® Times Cited:||23|
|Deposited By:||Menzies Institute for Medical Research|
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