NCT04666389

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

2.2 years

First QC Date

December 1, 2020

Last Update Submit

January 24, 2023

Conditions

Contrast-induced Acute Kidney InjuryCardiovascular Diseases

Keywords

contrast-induced acute kidney injurycontrast-associated acute kidney injurycontrast mediacardiovascular diseasescomputer tomography

Outcome Measures

Primary Outcomes (1)

  • Contrast-induced acute kidney injury

    Contrast induced acute kidney injury is defined as the 25% rise (or 0,5 mg/dl) of serum creatinine from baseline assessed 48 hours after administration of contrast media.

    48-72 hours after contrast media administration

Study Arms (3)

Control group

PLACEBO COMPARATOR

No statins being used for prevention

Drug: Atorvastatin

Low-dose statin therapy

ACTIVE COMPARATOR

Atorvastatin 40 mg

Drug: Atorvastatin

High-dose statin therapy

ACTIVE COMPARATOR

Atorvastatin 80 mg

Drug: Atorvastatin

Interventions

AtorvastatinDRUG

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

Control groupHigh-dose statin therapyLow-dose statin therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sechenov University

Moscow, Russia

Location

Related Publications (1)

  • Vasin AA, Mironova OI, Fomin VV. [The atorvastatin effects on the prevention of contrast-induced acute kidney injury during computed tomography with contrast media]. Ter Arkh. 2022 Oct 24;94(9):1057-1061. doi: 10.26442/0403660.2022.09.201845. Russian.

    PMID: 36286755DERIVED

Related Links

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Olga Mironova, MD PhD

    Sechenov University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 14, 2020

Study Start

October 15, 2020

Primary Completion

December 31, 2022

Study Completion

January 10, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)