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Statins for Prevention of Contrast Induced Nephropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mauro Maioli, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier:
NCT00770796
First received: October 9, 2008
Last updated: December 2, 2012
Last verified: December 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770796

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

No publications provided

Responsible Party: Mauro Maioli, MD, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier: NCT00770796     History of Changes
Other Study ID Numbers: Prato0702, POCARD0702
Study First Received: October 9, 2008
Last Updated: December 2, 2012
Health Authority: Italy: National Bioethics Committee

Keywords provided by Ospedale Misericordia e Dolce:
Contrast induced nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013