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Efficacy of Statins In Prevention of CIN (SCIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01071993
Recruitment Status : Terminated (Sponsor can not supply drugs anymore.)
First Posted : February 19, 2010
Results First Posted : September 13, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Tracking Information
First Submitted Date  ICMJE February 18, 2010
First Posted Date  ICMJE February 19, 2010
Results First Submitted Date  ICMJE April 7, 2017
Results First Posted Date  ICMJE September 13, 2017
Last Update Posted Date December 4, 2017
Study Start Date  ICMJE March 2010
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2017)
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 ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Statins In Prevention of CIN
Official Title  ICMJE Efficacy Of Statins In The Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Insufficiency (SCIN Trial): A Double-Blind, Placebo-Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Nephropathy
Intervention  ICMJE
  • Drug: placebo
    pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
  • Drug: atorvastatin
    pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
Study Arms  ICMJE
  • Active Comparator: atorvastatin
    Intervention: Drug: atorvastatin
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 14, 2017)
21
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2010)
200
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01071993
Other Study ID Numbers  ICMJE 15097
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No data was collected; therefore, a plan is not applicable.
Current Responsible Party University of Oklahoma
Original Responsible Party Mazen Abu-Fadel, M. D., Oklahoma University Health Sciences Center & VA Medical Center
Current Study Sponsor  ICMJE University of Oklahoma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mazen Abu-Fadel, M.D. Oklahoma Univeristy Health Science Center and VA Medical Center
PRS Account University of Oklahoma
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP