AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)

Phase 3CompletedNCT00240331

AstraZeneca2,776 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

2,776

Conditions

Interventions

10mg RosuvastatinDRUG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (239)

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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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.

Time frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

Data from ClinicalTrials.gov

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NCT00240331 - AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD) | Crick | Crick