Efficacy of Statins In Prevention of CIN (SCIN)

• ClinicalTrials.gov Identifier: NCT01071993
• Recruitment Status: Terminated
• First Posted: February 19, 2010
• Results First Posted: September 13, 2017
• Last Update Posted: December 4, 2017
• Sponsor: University of Oklahoma
• Information provided by (Responsible Party): University of Oklahoma

Tracking Information

• First Submitted Date: February 18, 2010
• First Posted Date: February 19, 2010
• Results First Submitted Date: April 7, 2017
• Results First Posted Date: September 13, 2017
• Last Update Posted Date: December 4, 2017
• Study Start Date: March 2010
• Actual Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Statins In Prevention of CIN
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Nephropathy

Intervention

• 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

• Active Comparator: atorvastatin
  Intervention: Drug: atorvastatin
• Placebo Comparator: placebo
  Intervention: Drug: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: August 14, 2017): 21
• Original Estimated Enrollment (submitted: February 18, 2010): 200
• Actual Study Completion Date: July 2013
• Actual Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01071993
• Other Study ID Numbers: 15097
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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: University of Oklahoma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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