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Statins for Prevention of Contrast Induced Nephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00770796
First Posted: October 10, 2008
Last Update Posted: October 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mauro Maioli, Ospedale Misericordia e Dolce
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Mauro Maioli, 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 ]

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 ]
  • Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration [ Time Frame: 1 month ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770796


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

Responsible Party: Mauro Maioli, MD, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier: NCT00770796     History of Changes
Other Study ID Numbers: Prato0702
First Submitted: October 9, 2008
First Posted: October 10, 2008
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by Mauro Maioli, Ospedale Misericordia e Dolce:
Contrast induced nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors