Statins for Prevention of Contrast Induced Nephropathy

Ospedale Misericordia e Dolce

Status and phase: Completed; Phase 4

Conditions: Contrast Induced Nephropathy

Treatments: Drug: Placebo; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00770796

Prato0702

Details and patient eligibility

About

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.

Enrollment: 304 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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304 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo

Atorvastatin

Active Comparator group

Description:

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

Treatment:

Drug: Atorvastatin