Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the project is to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury in patients with non-ST-elevation acute coronary syndromes scheduled for early invasive strategy.
This is a prospective, single-centre, randomized study, designed to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury (CI-AKI). Consecutive statin-naïve patients admitted in the investigators institution for non-ST elevation Acute Coronary Syndrome (NSTE-ACS) and scheduled for early invasive strategy will be eligible.
Patients are randomized into two groups: 1) high-dose rosuvastatin (40 mg on-admission followed by 20 mg/day); 2) high-dose atorvastatin (80 mg on-admission followed by 40 mg/day). Randomization will be performed on-admission by computerized open-label assignment in blinded envelopes used in a consecutive fashion. All patients receive the standard pre-procedural hydration. The primary end-point is the proportion of patients with an increase in serum creatinine of ≥ 0.5 mg/dl or ≥ 25% above baseline within 72 hours after contrast medium administration. The secondary end-points are persistent worsening of renal damage (eGFR reduction >= 25% at 30 days) and cumulative adverse clinical events at follow-up. Specifically: death, myocardial infarction, dialysis, stroke or persistent renal damage at 30 days; death or myocardial infarction at 6 and 12 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Active Comparator | Rosuvastatin (40 mg on-admission followed by 20 mg/day) until discharge; then 20 mg/day (10 mg/day if creatinine clearance < 30 ml/min) |
|
| Atorvastatin | Active Comparator | atorvastatin (80 mg on-admission followed by 40 mg/day before and after discharge) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug |
| ||
| Atorvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast Induced-Acute Kidney Injury | Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function at 30 days | Estimation of the glomerular filtration rate in all patients at 30 days | 30 days after discharge |
| Cardiovascular and renal outcome | Composite cardiovascular and renal events at follow-up including acute renal failure requiring dialysis, persistent renal damage, all-causes mortality, myocardial infarction or stroke. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anna Toso, MD | Prato Hospital, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Division, Prato Hospital | Prato | Prato | 59100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32434204 | Derived | Toso A, Leoncini M, Maioli M, Tropeano F, Villani S, Bellandi F. A Prospective, Randomized, Open-Label Trial of Atorvastatin versus Rosuvastatin in the Prevention of Contrast-Induced Acute Kidney Injury, Worsened Renal Function at 30 Days, and Clinical Events After Acute Coronary Angiography: the PRATO-ACS-2 Study. Cardiorenal Med. 2020;10(5):288-301. doi: 10.1159/000506857. Epub 2020 May 20. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 30 days, 6 months, 12 months |
| Anti-inflammatory effect of rosuvastatin and atorvastatin | High-sensitivity C-reactive protein (hs-CRP)will be measured on admission, at discharge and at 30 days. | On admission (baseline), at discharge (after 5 days) & at 30 days |
| Lipid-modulatory effects of atorvastatin and rosuvastatin | Low density lipoprotein (LDL) levels will be determined on admission, at discharge and at 30 days. | On admission (baseline), at discharge (after 5 days) & at 30 days |
| Myocardial Damage | Total cardiac biomarkers release during the index event | During hospitalization (average 5 days) |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |