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High Dose Atorvastatin for Preventing Contrast-induced Nephropathy

Primary Purpose

Contrast-Induced Nephropathy

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Atorvastatin
Placebo
0.9% sodium chloride
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast-Induced Nephropathy focused on measuring Computed Tomography Angiogram, Side Effects, Contrast-Induced Nephropathy, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Alzahra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atorvastatin

Placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2014
Last Updated
April 11, 2014
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02114346
Brief Title
High Dose Atorvastatin for Preventing Contrast-induced Nephropathy
Official Title
Evaluating the Effect of High Dose Atorvastatin (80 mg/d) Comparing With Placebo in Preventing Contrast-induced Nephropathy in Patients Undergoing Computed Tomography Coronary Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast-Induced Nephropathy
Keywords
Computed Tomography Angiogram, Side Effects, Contrast-Induced Nephropathy, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in the placebo group receive 2 placebo tablets once daily from 24 hours before to 48 hours after administration of contrast material.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plasma creatinine level
Description
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.
Time Frame
up to 48h after contrast injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Hajian, M.D.
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alzahra Hospital
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22511942
Citation
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.
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High Dose Atorvastatin for Preventing Contrast-induced Nephropathy

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