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临床试验/NCT01870804
NCT01870804已完成4 期

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.

Centro Cardiopatici Toscani1 个研究点 分布在 1 个国家目标入组 760 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

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

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

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)

干预措施: Rosuvastatin (Drug)

Atorvastatin

Active Comparator

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

发起方
Centro Cardiopatici Toscani
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Toso

MD

Ospedale Misericordia e Dolce

研究点 (1)

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