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

Sponsor
I.M. Sechenov First Moscow State Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04666389
Collaborator
(none)
150
1
3
45.5
3.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases
Actual Study Start Date :
Oct 15, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jul 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control group

No statins being used for prevention

Drug: Atorvastatin
To compare the preventive role of low- and high-dose statin regimens in the prevention on contrast-induced acute kidney injury in statin-naive patients with cardiovascular diseases undergoing computer tomography with intravenous contrast media administration

Active Comparator: Low-dose statin therapy

Atorvastatin 40 mg

Drug: Atorvastatin
To compare the preventive role of low- and high-dose statin regimens in the prevention on contrast-induced acute kidney injury in statin-naive patients with cardiovascular diseases undergoing computer tomography with intravenous contrast media administration

Active Comparator: High-dose statin therapy

Atorvastatin 80 mg

Drug: Atorvastatin
To compare the preventive role of low- and high-dose statin regimens in the prevention on contrast-induced acute kidney injury in statin-naive patients with cardiovascular diseases undergoing computer tomography with intravenous contrast media administration

Outcome Measures

Primary Outcome Measures

  1. Contrast-induced acute kidney injury [48-72 hours after contrast media administration]

    CI-AKI is defined as the 25% rise (or 0,5 mg/dl) of serum creatinine from baseline assessed 48 hours after administration of contrast media.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sechenov University Moscow Russian Federation

Sponsors and Collaborators

  • I.M. Sechenov First Moscow State Medical University

Investigators

  • Principal Investigator: Olga Mironova, MD PhD, Sechenov University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Olga Mironova, Associate Professor, I.M. Sechenov First Moscow State Medical University
ClinicalTrials.gov Identifier:
NCT04666389
Other Study ID Numbers:
  • 09/2020
First Posted:
Dec 14, 2020
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Olga Mironova, Associate Professor, I.M. Sechenov First Moscow State Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2022