ClinicalTrials.gov

History of Changes for Study: NCT01071993
Efficacy of Statins In Prevention of CIN (SCIN)
Latest version (submitted October 27, 2017) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 February 18, 2010 None (earliest Version on record)
2 November 15, 2010 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 August 30, 2012 Contacts/Locations, Study Status and Sponsor/Collaborators
4 February 4, 2013 Study Status
5 February 13, 2014 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 August 14, 2017 Study Status, Outcome Measures, Results, IPDSharing, Eligibility and Study Design
7 October 27, 2017 Study Status and Outcome Measures
Comparison Format:

Scroll up to access the controls

Study NCT01071993
Submitted Date:  February 18, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: 15097
Brief Title: Efficacy of Statins In Prevention of CIN (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
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2010
Overall Status: Not yet recruiting
Study Start: March 2010
Primary Completion: December 2011 [Anticipated]
Study Completion: February 2012 [Anticipated]
First Submitted: February 18, 2010
First Submitted that
Met QC Criteria:
February 18, 2010
First Posted: February 19, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 18, 2010
Last Update Posted: February 19, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Oklahoma
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Nephropathy
Keywords: prevention
nephropathy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
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)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Reji M Pappy, M.D.
Telephone: 4052105652
Email: reji-pappy@ouhsc.edu
Central Contact Backup: Mazen Abu-Fadel, M.D.
Telephone: 4052718000
Email: mazen-abufadel@ouhsc.edu
Study Officials: Mazen Abu-Fadel, M.D.
Principal Investigator
Oklahoma Univeristy Health Science Center and VA Medical Center
Locations: United States, Oklahoma
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, United States, 73104
Contact:Contact: Reji M Pappy, M.D. 405-210-5652 reji-pappy@ouhsc.edu
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services