Back to resultsEfficacy of Statins In Prevention of CIN (SCIN)
Primary Purpose
Nephropathy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
placebo
atorvastatin
Sponsored by
About this trial
This is an interventional prevention trial for Nephropathy focused on measuring prevention, nephropathy
Eligibility Criteria
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
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
Sites / Locations
- Oklahoma University Health Science Center
- Veterans Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
atorvastatin
placebo
Arm Description
Outcomes
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01071993
First Posted
February 18, 2010
Last Updated
October 27, 2017
Sponsor
University of Oklahoma
1. Study Identification
Unique Protocol Identification Number
NCT01071993
Brief Title
Efficacy of Statins In Prevention of CIN
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Sponsor can not supply drugs anymore.
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephropathy
Keywords
prevention, nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
atorvastatin
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Description
pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
Primary Outcome Measure Information:
Title
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.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mazen Abu-Fadel, M.D.
Organizational Affiliation
Oklahoma Univeristy Health Science Center and VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oklahoma University Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Veterans Affairs Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data was collected; therefore, a plan is not applicable.
Learn more about this trial
Efficacy of Statins In Prevention of CIN
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