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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo |
|
| Atorvastatin | Active Comparator | 80 mg die of Atorvastatin given at least two days before elective angiography or angioplasty and continued for two days after. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 80 mg die |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauro Maioli, MD | Ospedale Misericordia e Dolce, Prato | Principal Investigator |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
| 1 month |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |