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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

AURORA: Crestor 10mg versus placebo in subjects with End-stage Renal Disease (ESRD)

Research Site

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

Age Continuous

Gender, Male/Female

The endpoints were originally intended to be time to event endpoints, however we are unable to report the data as intended due to the nature of time to event endpoints.  Therefore we have reported the number of participants who reached the event.

Number of randomised participants with a major cardiovascular event (non-fatal stroke, non-fatal myocardial infarction or cardiovascular death)

Number of randomised participants that died from any cause.

Number of randomised participants with a major cardiovascular event or that died from any known cause

Number of randomised participants that died from cardiovascular cause

Number of randomised participants that died from non cardiovascular cause

Number of randomised participants with an atherosclerotic cardiac event (non-fatal myocardial infarction or Coronary Heart Disease (CHD) death)

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.

Number of randomised participants that experienced a coronary or peripheral revascularisation (including above ankle limb amputations).

Overall Study

After a two week screening period, eligible patients were randomly assigned to either rosuvastatin treatment (10mg/day) or placebo with a 1:1 randomisation ratio. Follow-up was planned to continue until the accrual of 805 major cardiovascular events

Arms	Assigned Interventions
Experimental: Rosuvastatin 10mg	-
Placebo Comparator: Placebo matching Placebo	-

AURORA: Crestor 10mg versus placebo in subjects with End-stage Renal Disease (ESRD)

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=223&filename=CSR-4522IL-0096 Dutch.pdf

CSR-4522IL-0096.pdf

CSR-4522IL-0096.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator