High Dose Atorvastatin for Preventing Contrast-induced Nephropathy

Phase 2

Completed

• Conditions: Contrast-Induced Nephropathy
• Interventions: Drug: Placebo; Drug: Atorvastatin; Drug: 0.9% sodium chloride

• Registration Number: NCT02114346
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-04
• Study First Submitted: 2014-04-11
• Study First Submitted QC: 2014-04-11
• Last Update Submitted: 2014-04-11
• Study First Posted: 2014-04-15
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients in the placebo group receive 2 placebo tablets once daily from 24 hours before to 48 hours after administration of contrast material.
Atorvastatin	0.9% sodium chloride	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.
Placebo	0.9% sodium chloride	Patients in the placebo group receive 2 placebo tablets once daily from 24 hours before to 48 hours after administration of contrast material.
Atorvastatin	Atorvastatin	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.

Primary Outcome Measures

Name	Time	Method
Plasma creatinine level	up to 48h after contrast injection	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.

Trial Locations

Locations (1)

Alzahra Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of