Efficacy of Statins In Prevention of CIN

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy Of Statins In The Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Insufficiency (SCIN Trial): A Double-Blind, Placebo-Controlled Trial

Conditions
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Nephropathy

Intervention / Treatment
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* Drug: placebo
* Drug: atorvastatin


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: atorvastatin<br> | Drug: atorvastatin<br>* pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, nephropathy