Statins for Prevention of Contrast Induced Nephropathy

Sponsor

Ospedale Misericordia e Dolce (Other)

Overall Status

Completed

CT.gov ID

NCT00770796

Collaborator

(none)

304

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Contrast Induced Nephropathy	Drug: Atorvastatin Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

304 participants

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

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 [within 5 days after contrast exposure]

Secondary Outcome Measures

Relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration [within 5 days after contrast agent administration]
Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Ospedale Misericordia e Dolce

Investigators

Principal Investigator: Mauro Maioli, MD, Ospedale Misericordia e Dolce, Prato

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mauro Maioli, MD, Ospedale Misericordia e Dolce

ClinicalTrials.gov Identifier:

NCT00770796

Other Study ID Numbers:

Prato0702

First Posted:

Oct 10, 2008

Last Update Posted:

Oct 16, 2015

Last Verified:

Oct 1, 2015

Keywords provided by Mauro Maioli, MD, Ospedale Misericordia e Dolce

Contrast induced nephropathy

Additional relevant MeSH terms:

Kidney Diseases

Atorvastatin

Study Results

No Results Posted as of Oct 16, 2015