Statins for Prevention of Contrast Induced Nephropathy

In this randomized study the investigators wish to explore the role of pre-procedural statin therapy for the prevention of contrast induced nephropathy in patients with moderate-to-severe renal dysfunction, submitted to elective coronary or angioplasty.

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Key information

Conditions

Contrast Induced Nephropathy

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with pre-angiographic estimated creatinine clearance < 60 ml/min

Exclusion criteria

contrast medium administration within the previous 10 days
end-stage renal failure requiring dialysis
refusal to give informed consent
previous therapy with statin

Treatment and study plan

atorvastatin

Drug

80 mg die

Placebo

Drug

Primary outcomes

Contrast-induced nephropathy was defined as an absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration within the first 24 hours after contrast exposure and peaking up to 5 days afterwards

Time frame: within 5 days after contrast exposure

Secondary outcomes

Relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration

Time frame: within 5 days after contrast agent administration
Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration

Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Ospedale Misericordia e Dolce

Other

Registry information

Official study title

Usefulness of Atorvastatin (80 mg) in Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Disease

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Oct 10, 2008
Registry last updated: Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed