Statins for Prevention of Contrast Induced Nephropathy

This study has been completed.
Information provided by (Responsible Party):
Mauro Maioli, Ospedale Misericordia e Dolce Identifier:
First received: October 9, 2008
Last updated: October 15, 2015
Last verified: October 2015
In this randomized study the investigators wish to explore the role of pre-procedural statin therapy for the prevention of contrast induced nephropathy in patients with moderate-to-severe renal dysfunction, submitted to elective coronary or angioplasty.

Condition Intervention Phase
Contrast Induced Nephropathy
Drug: Atorvastatin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Usefulness of Atorvastatin (80 mg) in Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Disease

Resource links provided by NLM:

Further study details as provided by Ospedale Misericordia e Dolce:

Primary Outcome Measures:
  • Contrast-induced nephropathy was defined as an absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration within the first 24 hours after contrast exposure and peaking up to 5 days afterwards [ Time Frame: within 5 days after contrast exposure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration [ Time Frame: within 5 days after contrast agent administration ] [ Designated as safety issue: Yes ]
  • Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 304
Study Start Date: April 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: Atorvastatin
80 mg die of Atorvastatin given at least two days before elective angiography or angioplasty and continued for two days after.
Drug: Atorvastatin
80 mg die


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients with pre-angiographic estimated creatinine clearance < 60 ml/min

Exclusion Criteria:

  • contrast medium administration within the previous 10 days
  • end-stage renal failure requiring dialysis
  • refusal to give informed consent
  • previous therapy with statin
  Contacts and Locations
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Please refer to this study by its identifier: NCT00770796

Sponsors and Collaborators
Ospedale Misericordia e Dolce
Principal Investigator: Mauro Maioli, MD Ospedale Misericordia e Dolce, Prato
  More Information

No publications provided

Responsible Party: Mauro Maioli, MD, Ospedale Misericordia e Dolce Identifier: NCT00770796     History of Changes
Other Study ID Numbers: Prato0702
Study First Received: October 9, 2008
Last Updated: October 15, 2015
Health Authority: Italy: National Bioethics Committee

Keywords provided by Ospedale Misericordia e Dolce:
Contrast induced nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on December 01, 2015