Phase 3
Completed N=2,773
AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
Source: ClinicalTrials.gov NCT00240331 ↗Enrolled (actual)
2,773
Serious AEs
—
Results posted
Nov 2009
Primary outcomePrimary: Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death) — 396; 408 Participants
Summary
The purpose of this study is to see if rosuvastatin helps to reduce the number of heart attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death) |
396; 408 | — |
| SECONDARY Number of Randomised Participants That Died From Any Cause. |
636; 660 | — |
| SECONDARY Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause |
614; 645 | — |
| SECONDARY Number of Randomised Participants That Died From Cardiovascular Cause |
324; 324 | — |
| SECONDARY Number of Randomised Participants That Died From Non Cardiovascular Cause |
— | — |
| SECONDARY Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death) |
258; 256 | — |
| SECONDARY Number of Randomised Participants That Experienced a Procedure as a Result of Stenosis or Thrombosis of the Vascular Access (Arteriovenous (AV) Fistulas and Grafts Only) for Haemodialysis. |
390; 360 | — |
| SECONDARY Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations). |
148; 152 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects with end-stage renal failure aged 50-80 years, who have received regular haemodialysis treatment for at least 3 months
Exclusion Criteria
- Subjects will have no underlying condition that is expected to limit survival to less than 1 year and is also unrelated to end-stage renal disease (ESRD). Subjects should not have received a statin therapy within the past 6 months
Data sourced from ClinicalTrials.gov (NCT00240331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.