NCT00240331CompletedPhase 3
A Study to Evaluate the Use of Rosuvastatin in Subjects On Regular Haemodialysis: an Assessment of Survival and Cardiovascular Events (AURORA). A Double Blind, Randomised, Phase 3b, Parallel-group Study to Compare the Effects of Rosuvastatin With Placebo on Assessment of Survival & Cardiovascular Events When Given to Subjects With End-stage Renal Failure on Chronic Haemodialysis Treatment
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 2,776
- Locations
- 1
- Primary Endpoint
- Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Rosuvastatin 10mg
Experimental
Intervention: 10mg Rosuvastatin (Drug)
Placebo
Placebo Comparator
matching Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)
Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Secondary Outcomes
- Number of Randomised Participants That Died From Any Cause.(Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years)
- Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause(Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years)
- Number of Randomised Participants That Died From Cardiovascular Cause(Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years)
- Number of Randomised Participants That Died From Non Cardiovascular Cause(Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years)
- Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)(Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years)
- 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.(Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years)
- Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).(Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years)
Investigators
Study Sites (1)
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