High Dose Atorvastatin for Preventing Contrast-induced Nephropathy

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Contrast-Induced Nephropathy

Treatments: Drug: 0.9% sodium chloride; Drug: Atorvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02114346

392353

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups, including a placebo group

Atorvastatin

Experimental group

Description:

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.

Treatment:

Drug: 0.9% sodium chloride

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

Patients in the placebo group receive 2 placebo tablets once daily from 24 hours before to 48 hours after administration of contrast material.

Treatment:

Drug: 0.9% sodium chloride

Drug: Placebo