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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nephropathy Drug: placebo Drug: atorvastatin Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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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 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071993


Locations
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United States, Oklahoma
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, United States, 73104
Veterans Affairs Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Mazen Abu-Fadel, M.D. Oklahoma Univeristy Health Science Center and VA Medical Center
More Information
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01071993    
Other Study ID Numbers: 15097
First Posted: February 19, 2010    Key Record Dates
Results First Posted: September 13, 2017
Last Update Posted: December 4, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data was collected; therefore, a plan is not applicable.
Keywords provided by University of Oklahoma:
prevention
nephropathy
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors