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

Citation

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 Statement

Copyright 2017 World Stroke Organization

DOI: doi:10.1177/1747493017741383

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 Details

Item Type:Contribution to Refereed Journal
Keywords:aspirin, clinical trial, disability free survival, intracerebral hemorrhage, ischemic stroke, protocols, statistical analysis plan
Research Division:Medical and Health Sciences
Research Group:Cardiorespiratory Medicine and Haematology
Research Field:Cardiology (incl. Cardiovascular Diseases)
Objective Division:Health
Objective Group:Clinical Health (Organs, Diseases and Abnormal Conditions)
Objective Field:Cardiovascular System and Diseases
UTAS Author:Nelson, MR (Professor Mark Nelson)
ID Code:126260
Year Published:2018
Web of Science® Times Cited:4
Deposited By:Menzies Institute for Medical Research
Deposited On:2018-05-31
Last Modified:2019-09-11
Downloads:0

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