The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases

I.M. Sechenov First Moscow State Medical University

Status: Completed

Conditions: Contrast-induced Acute Kidney Injury; Cardiovascular Diseases

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04666389

09/2020

Details and patient eligibility

About

The aim of the study is to assess the role of statins and different dosage regimens in the prevention of contrast-induced acute kidney injury in patients with cardiovascular diseases requiring intravenous contrast media administration before computer tomography

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• Indications for computer tomography with intravenous contrast media administration
• Cardiovascular diseases (arterial hypertension, arrhythmia etc)

Exclusion criteria

• Pregnancy
• Statin therapy before inclusion in the study
• Acute coronary syndromes
• Contraindications for statins administration
• Patients with chronic kidney disease stages 4-5
• Contraindications for computer tomography with contrast media administration
• Nephrotoxic drugs use (NSAIDS, vancomycin etc)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

No statins being used for prevention

Treatment:

Drug: Atorvastatin

Low-dose statin therapy

Active Comparator group

Description:

Atorvastatin 40 mg

Treatment:

Drug: Atorvastatin

High-dose statin therapy

Active Comparator group

Description:

Atorvastatin 80 mg

Treatment:

Drug: Atorvastatin