Statins for Prevention of Contrast Induced Nephropathy
- Registration Number
- NCT00770796
- Lead Sponsor
- Ospedale Misericordia e Dolce
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo placebo Atorvastatin Atorvastatin 80 mg die of Atorvastatin given at least two days before elective angiography or angioplasty and continued for two days after.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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