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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Nephropathy
Interventions Drug: placebo
Drug: atorvastatin
Enrollment 21
Recruitment Details Participants were recruited and signed consent. No drugs were supplied to participants. Study sponsor could not provide study drugs to participants due to cost restraints.
Pre-assignment Details Prior to assigning participants to specific arms of the protocol, site was informed that the study drug was no longer available.
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
Period Title: Overall Study
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title Atorvastatin Placebo Total
Hide Arm/Group Description atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
Participants signed consent; however, study was terminated prior to randomization.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Age, Continuous  
Number Analyzed 0 participants 0 participants 0 participants
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants
1.Primary Outcome
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants signed consent; however, study was terminated prior to randomization
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description:
atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Not applicable/study was terminated prior to randomization.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
All-Cause Mortality
Atorvastatin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Atorvastatin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atorvastatin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Study Sponsor no longer supplied study drug/placebo.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mazen Abu-Fadel, MD
Organization: University of Oklahoma
Phone: 405-271-4742
EMail: mazen-abufadel@ouhsc.edu
Layout table for additonal information
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01071993    
Other Study ID Numbers: 15097
First Submitted: February 18, 2010
First Posted: February 19, 2010
Results First Submitted: April 7, 2017
Results First Posted: September 13, 2017
Last Update Posted: December 4, 2017