TerminatedNot Applicable

Efficacy of Statins In Prevention of CIN

Stopped: Sponsor can not supply drugs anymore.

United States21 participantsStarted 2010-03

Plain-language summary

To determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

1. Inclusion Criteria: * Adults \> 18 years of age * undergoing coronary or peripheral angiography with or without intervention * Cr \> 1.3 mg/dL or GFR \< 60 mL/min 2. Exclusion Criteria: * end-stage renal disease on dialysis * acute renal failure * previous iodinated contrast media exposure within 7 days of study entry * history of hypersensitivity to statins * pregnancy or lactation * emergent coronary angiography, ST elevation myocardial infarction (STEMI), or cardiogenic shock * prisoners * patients already on maximum dose of statins * patient receiving N-acetylcysteine or sodium bicarbonate

What they're measuring

Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours.

Timeframe: 48 hours

Trial details

NCT IDNCT01071993

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-07

Results submitted2017-04-07

View on ClinicalTrials.gov More Nephropathy trials