High Dose Atorvastatin for Preventing Contrast-induced Nephropathy

Study Overview
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Brief Summary
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The aim of this study is to determine the efficacy of atorvastatin in the prevention of contrast-induced nephropathy in patients undergoing computed tomography coronary angiography. Investigators assume that atorvastatin is effective in this regard. Investigators include patients referring for elective computed tomography coronary angiography and allocate them to atorvastatin or placebo from 24 hours before to 48 hours after administration of contrast material. Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL or ≥ 25% of the baseline value.

Official Title
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Evaluating the Effect of High Dose Atorvastatin (80 mg/d) Comparing With Placebo in Preventing Contrast-induced Nephropathy in Patients Undergoing Computed Tomography Coronary Angiography

Conditions
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Contrast-Induced Nephropathy

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Placebo
* Drug: 0.9% sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients candidate of elective computed tomography angiogram willingness to participate Exclusion Criteria: unstable angina or myocardial infarction, cardiac arrhythmia, seizures, acute renal failure, end-stage renal disease unstable serum creatinine unstable hemodynamic intravascular administration of contrast material in the past month using high dose atorvastatin in the past month, known hypersensitivity to atorvastatin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin<br>Patients in the atorvastatin group receive 80 mg atorvastatin (2 x atorvastatin 40 mg tablets) once daily from 24 hours before to 48 hours after administration of contrast material. | Drug: Atorvastatin<br> <br> Drug: 0.9% sodium chloride<br>* Patients with estimated glomerular filtration rate of less than 60 mL/min/1.73 m2 are hydrated with 0.9% sodium chloride for 2 hours, from 1 hour before (3 mL/kg/hour) to 1 hour after (1 mL/kg/hour) operation. Patients with left ventricular ejection fraction less than 40% or New York Heart Association functional class III-IV, are hydrated with 0.5 mL/kg/hour.<br>|
| Placebo Comparator: Placebo<br>Patients in the placebo group receive 2 placebo tablets once daily from 24 hours before to 48 hours after administration of contrast material. | Drug: Placebo<br> <br> Drug: 0.9% sodium chloride<br>* Patients with estimated glomerular filtration rate of less than 60 mL/min/1.73 m2 are hydrated with 0.9% sodium chloride for 2 hours, from 1 hour before (3 mL/kg/hour) to 1 hour after (1 mL/kg/hour) operation. Patients with left ventricular ejection fraction less than 40% or New York Heart Association functional class III-IV, are hydrated with 0.5 mL/kg/hour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma creatinine level | Plasma creatinine level is measured at baseline and after 48 hours of contrast injection. Increase in plasma creatinine level ≥ 0.5 mg/dL or ≥ 25% of the baseline creatinine after 48 hours of contrast injection will be considered contrast induced nephropathy. | up to 48h after contrast injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computed Tomography Angiogram, Side Effects, Contrast-Induced Nephropathy, Prevention