Statins for Prevention of Contrast Induced Nephropathy

NCT ID: NCT00770796

Last Updated: 2015-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Contrast Induced Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Atorvastatin

80 mg die of Atorvastatin given at least two days before elective angiography or angioplasty and continued for two days after.

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

80 mg die

Interventions

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Atorvastatin

80 mg die

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Misericordia e Dolce

OTHER

Sponsor Role lead

Responsible Party

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Mauro Maioli

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mauro Maioli, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Misericordia e Dolce, Prato

Other Identifiers

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Prato0702

Identifier Type: -

Identifier Source: org_study_id

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