Efficacy of Statins In Prevention of CIN

Not Applicable

Terminated

• Conditions: Nephropathy
• Interventions: Drug: placebo; Drug: atorvastatin

• Registration Number: NCT01071993
• Lead Sponsor: University of Oklahoma

Brief 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.

Detailed Description

Due to the conflict in the available data, there are no practice guidelines that are established in order to prevent contrast-induced nephropathy (CIN). Our goal is 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.

Study Timeline

• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-18
• Study First Posted: 2010-02-19
• Study Start: 2010-03
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2017-04-07
• Results First Submitted QC: 2017-08-14
• Results First Posted: 2017-09-13
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
atorvastatin	atorvastatin	-

Primary Outcome Measures

Name	Time	Method
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.	48 hours	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

Trial Locations

Locations (2)

Oklahoma University Health Science Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Veterans Affairs Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States