High Dose Atorvastatin for Preventing Contrast-induced Nephropathy

NCT02114346 | Completed Phase 2

• 1 other identifier: 392353
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast-Induced Nephropathy

Keywords

Computed Tomography Angiogram; Side Effects; Contrast-Induced Nephropathy; Prevention

Outcome Measures

Primary Outcomes (1)

• Plasma creatinine level

  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.

  up to 48h after contrast injection

Study Arms (2)

Atorvastatin

EXPERIMENTAL

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.

Drug: Atorvastatin; Drug: 0.9% sodium chloride

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: 0.9% sodium chloride

Interventions

Atorvastatin DRUG

Atorvastatin

Placebo DRUG

Placebo

0.9% sodium chloride DRUG

Patients with estimated glomerular filtration rate of less than 60 mL/min/1.73 m2 are hydrated with 0.9% sodium chloride for 2 hours, from 1 hour before (3 mL/kg/hour) to 1 hour after (1 mL/kg/hour) operation. Patients with left ventricular ejection fraction less than 40% or New York Heart Association functional class III-IV, are hydrated with 0.5 mL/kg/hour.

Atorvastatin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients
• candidate of elective computed tomography angiogram
• willingness to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Alzahra Hospital

Isfahan, Isfahan, Iran

Location

Related Publications (1)

• Li Y, Liu Y, Fu L, Mei C, Dai B. Efficacy of short-term high-dose statin in preventing contrast-induced nephropathy: a meta-analysis of seven randomized controlled trials. PLoS One. 2012;7(4):e34450. doi: 10.1371/journal.pone.0034450. Epub 2012 Apr 12.

  PMID: 22511942 BACKGROUND

MeSH Terms

Interventions

Atorvastatin; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Alireza Hajian, M.D.

  Isfahan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 15, 2014
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

IR (1)