Efficacy of Statins In Prevention of CIN

Nephropathy Clinical Trial

— SCIN  

Official title:

Efficacy Of Statins In The Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Insufficiency (SCIN Trial): A Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01071993
• Other study ID #: 15097
• Status: Terminated
• Phase: N/A
• First received: February 18, 2010
• Last updated: October 27, 2017
• Start date: March 2010
• Est. completion date: July 2013

Study information

• Verified date: October 2017
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Nephropathy

Intervention

Drug:
• placebo
pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
• atorvastatin
pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)

Locations

Country	Name	City	State
United States	Oklahoma University Health Science Center	Oklahoma City	Oklahoma
United States	Veterans Affairs Medical Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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