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

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 durat...

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Main 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.
Format: Journal Article
Published: Wiley-Blackwell Publishing Asia 2018
Online Access:http://hdl.handle.net/20.500.11937/67682
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author 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.
author_facet 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.
author_sort Wolfe, R.
building Curtin Institutional Repository
collection Online Access
description 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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spelling curtin-20.500.11937-676822018-09-28T03:35:24Z The aspirin in reducing events in the elderly trial: Statistical analysis plan 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. 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). 2018 Journal Article http://hdl.handle.net/20.500.11937/67682 10.1177/1747493017741383 Wiley-Blackwell Publishing Asia restricted
spellingShingle 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.
The aspirin in reducing events in the elderly trial: Statistical analysis plan
title The aspirin in reducing events in the elderly trial: Statistical analysis plan
title_full The aspirin in reducing events in the elderly trial: Statistical analysis plan
title_fullStr The aspirin in reducing events in the elderly trial: Statistical analysis plan
title_full_unstemmed The aspirin in reducing events in the elderly trial: Statistical analysis plan
title_short The aspirin in reducing events in the elderly trial: Statistical analysis plan
title_sort aspirin in reducing events in the elderly trial: statistical analysis plan
url http://hdl.handle.net/20.500.11937/67682