Efficacy of Statins In Prevention of CIN (SCIN)
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nephropathy | Drug: placebo Drug: atorvastatin | Not Applicable |
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 |

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) |
- 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

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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 |
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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
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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

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
United States, Oklahoma | |
Oklahoma University Health Science Center | |
Oklahoma City, Oklahoma, United States, 73104 | |
Veterans Affairs Medical Center | |
Oklahoma City, Oklahoma, United States, 73104 |
Principal Investigator: | Mazen Abu-Fadel, M.D. | Oklahoma Univeristy Health Science Center and VA Medical Center |
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. |
prevention nephropathy |
Kidney Diseases Urologic Diseases Atorvastatin Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |