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Efficacy of Statins In Prevention of CIN (SCIN)

This study is currently recruiting participants.
Verified February 2013 by University of Oklahoma
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01071993
First received: February 18, 2010
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Nephropathy
 Drug: placebo
Drug: atorvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: atorvastatin Drug: atorvastatin
pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
Placebo Comparator: placebo Drug: placebo
pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071993

Contacts
Contact: Talla Rousan, M.D. 4052715963 talla-rousan@ouhsc.edu
Contact: Mazen Abu-Fadel, M.D. 4052718000 mazen-abufadel@ouhsc.edu

Locations
United States, Oklahoma
Oklahoma University Health Science Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Talla Rousan, M.D.     405-271-5963     talla-rousan@ouhsc.edu    
Veterans Affairs Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Talla Rousan, MD     405-271-5963     talla-rousan@ouhsc.edu    
Principal Investigator: Mazen Abu-Fadel, MD            
Sub-Investigator: Talla Rousan, MD            
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Mazen Abu-Fadel, M.D. Oklahoma Univeristy Health Science Center and VA Medical Center
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01071993     History of Changes
Other Study ID Numbers: 15097
Study First Received: February 18, 2010
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
prevention
nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013