A randomised clinical trial of STAtin therapy for Reducing Events in the Elderly (STAREE): Statistical analysis plan

  1. Rory Wolfe
  2. Stephane Heritier
  3. Ella Zomer
  4. Mary Lou Chatterton
  5. Andrea Curtis
  6. Simone Spark
  7. Zachary Flanagan
  8. Trever T-J Chong
  9. Geoffrey C Cloud
  10. Mark R Nelson
  11. Stephen J Nicholls
  12. Chris Moran
  13. Christopher M Reid
  14. Sophia Zoungas
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Abstract

The STAREE randomised controlled trial of 9971 community-dwelling older adults without cardiovascular disease, diabetes or dementia is designed to compare daily 40mg atorvastatin to placebo. We present a statistical analysis plan to pre-specify the analytical approaches that will be taken when reporting the main findings from the trial. The plan describes the analysis approach for the co-primary endpoints: (a) death, dementia, and persistent physical disability; (b) major cardiovascular events; and all secondary endpoints. A pre-specified economic evaluation is also included as part of this plan.

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