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: August 24, 2014
Last verified: August 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 24, 2014
Health Authority: Italy: National Bioethics Committee

Keywords provided by Ospedale Misericordia e Dolce:
Contrast induced nephropathy

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

ClinicalTrials.gov processed this record on October 23, 2014