Impact of Early High-dose Atorvastatin Versus Rosuvastatin on Contrast Induced Acute Kidney Injury in Unselected Patients With Non- ST Elevation Acute Coronary Syndromes Scheduled for Early Invasive Strategy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 760
- 试验地点
- 1
- 主要终点
- Contrast Induced-Acute Kidney Injury
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive statin-naive patients with non ST-elevation acute coronary syndrome admitted to our institution and scheduled for early invasive strategy are considered for enrollment
排除标准
- •Current statin treatment
- •High-risk features warranting emergency coronary angiography (within 2 hours)
- •Acute renal failure or end-stage renal failure requiring dialysis or serum creatinine ≥ 3 mg/dl
- •Severe comorbidities which precluded early invasive strategy
- •Contraindications to statin treatment
- •Contrast media administration within the last 10 days
- •Pregnancy
- •Refusal of consent
研究组 & 干预措施
Rosuvastatin
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)
干预措施: Rosuvastatin (Drug)
Atorvastatin
atorvastatin (80 mg on-admission followed by 40 mg/day before and after discharge)
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Contrast Induced-Acute Kidney Injury
时间窗: 72 hours
Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure
次要结局
- Renal function at 30 days(30 days after discharge)
- Cardiovascular and renal outcome(30 days, 6 months, 12 months)
- Myocardial Damage(During hospitalization (average 5 days))
- Anti-inflammatory effect of rosuvastatin and atorvastatin(On admission (baseline), at discharge (after 5 days) & at 30 days)
- Lipid-modulatory effects of atorvastatin and rosuvastatin(On admission (baseline), at discharge (after 5 days) & at 30 days)
研究者
Anna Toso
MD
Ospedale Misericordia e Dolce
