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).
| Original language | English |
|---|---|
| Pages (from-to) | 335-338 |
| Number of pages | 4 |
| Journal | International Journal of Stroke |
| Volume | 13 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 1 Apr 2018 |
Keywords
- Aspirin
- clinical trial
- disability free survival
- intracerebral hemorrhage
- ischemic stroke
- protocols
- statistical analysis plan
Cite this
}
The aspirin in reducing events in the elderly trial : Statistical analysis plan. / Wolfe, Rory; Murray, Anne M.; Woods, Robyn L.; Kirpach, Brenda; Gilbertson, David; Shah, Raj C.; Nelson, Mark R.; Reid, Christopher M.; Ernst, Michael E.; Lockery, Jessica; Donnan, Geoffrey A.; Williamson, Jeff; McNeil, John J.
In: International Journal of Stroke, Vol. 13, No. 3, 01.04.2018, p. 335-338.Research output: Contribution to journal › Review Article › Other › peer-review
TY - JOUR
T1 - The aspirin in reducing events in the elderly trial
T2 - Statistical analysis plan
AU - Wolfe, Rory
AU - Murray, Anne M.
AU - Woods, Robyn L.
AU - Kirpach, Brenda
AU - Gilbertson, David
AU - Shah, Raj C.
AU - Nelson, Mark R.
AU - Reid, Christopher M.
AU - Ernst, Michael E.
AU - Lockery, Jessica
AU - Donnan, Geoffrey A.
AU - Williamson, Jeff
AU - McNeil, John J.
PY - 2018/4/1
Y1 - 2018/4/1
N2 - 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).
AB - 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).
KW - Aspirin
KW - clinical trial
KW - disability free survival
KW - intracerebral hemorrhage
KW - ischemic stroke
KW - protocols
KW - statistical analysis plan
UR - http://www.scopus.com/inward/record.url?scp=85044386393&partnerID=8YFLogxK
U2 - 10.1177/1747493017741383
DO - 10.1177/1747493017741383
M3 - Review Article
VL - 13
SP - 335
EP - 338
JO - International Journal of Stroke
JF - International Journal of Stroke
SN - 1747-4930
IS - 3
ER -