High Dose Atorvastatin for Preventing Contrast-induced Nephropathy

Contrast-Induced Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02114346
• Other study ID #: 392353
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 11, 2014
• Last updated: April 11, 2014
• Start date: July 2013
• Est. completion date: February 2014

Study information

• Verified date: April 2014
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast-Induced Nephropathy
• Kidney Diseases

Intervention

Drug:
• Atorvastatin

• Placebo

• 0.9% sodium chloride
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Alzahra Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No