Preventive Effect of the PRetreatment With pItavastatiN on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndErgoing Coronary Angiography/Intervention (PRINCIPLE-II Study)
试验速览
- 阶段
- 4 期
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Incidence of contrast-induced nephropathy
研究概览
简要总结
Contrast-induced nephropathy (CIN) is a well-recognized complication of radiographic contrast administration and is associated with increased short- and long-term mortality. Previous strategies including forced diuresis with diuretics or mannitol, intravenous administration of fenoldopam or dobutamine, and postprocedure hemodialysis to prevent CIN have been largely unsuccessful. In addition, the use of N-acetylcysteine to prevent CIN has yielded conflicting outcomes.
A review of a large insurance database and retrospective study have shown that statins therapy is associated with a lower incidence of CIN after percutaneous coronary intervention. The preventive effect of statins on CIN may be attributed to direct pleiotropic effects on the vascular wall such as improvement of endothelial dysfunction, anti-inflammatory or anti-oxidative effect. However, recent randomized trial could not demonstrate the preventive effect of statin on CIN in patients with chronic kidney disease.
Thus, we will investigate the preventive effect of pitavastatin on CIN in patient with renal dysfunction undergoing coronary angiography or intervention.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years
- •Need for coronary angiography or intervention in patients with typical symptoms for angina or myocardial infarction, or documented myocardial ischemia at non-invasive studies including ECG, treadmill ECG test, heart spect or coronary CT angiography
- •Estimated glomerular filtration rate ≤60 mL/min
- •Informed consent
排除标准
- •Need for primary percutaneous coronary intervention or emergent intervention in patients with myocardial infarction
- •Allergic reaction for contrast agent (Visipaque) or statin
- •Contraindication for contrast agent (Visipaque) or statin
- •Shock status fron any cause including cardiogenic shock
- •Statin use before enrollment (Enrollment after 2 weeks of wash-out period)
- •Exposure of contrast agent within 7 days before enrollment
- •Pregnancy or Expectation for pregnancy in women of childbearing age
- •Heart failure (NYHA class ≥3 or left ventricular ejection fraction < 40%)
- •Acute renal injury
- •Dialysis therapy
- •Mechanical ventilator
- •Life expectancy < 6 months
- •Non-steroidal anti-inflammatory drug, dopamine, mannitol or N-acetylcysteine, ascorbic acid within 48 hours before and after coronary angiography/intervention
- •Severe hepatic dysfunction
- •Eisenmenger syndrome or idiopathic pulmonary hypertension
- •Renal artery angioplasty within 6 months
- •Single functioning kidney
- •Kidney transplantation
研究组 & 干预措施
Pitavastatin
Pitavastatin 4 mg/day for 7 days before coronary angiography/intervention
干预措施: Pitavastatin (Drug)
Placebo
Placebo tablet for 7 days before coronary angiography/intervention
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of contrast-induced nephropathy
时间窗: 48 hours
Contrast-induced nephropathy is defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0.5 mg/dL after coronary angiography or intervention.
次要结局
- Length of hospital stay(an expected average of 5 weeks)
- Peak level of serum creatinine(48 hours)
- serum cystatin-C level(24 hours)
- serum neutrophil-gelatinase-associated lipocalin(NGAL) level(4 hours)
- Clinical events(1 month)
研究者
Woong Chol Kang
Associate Professor
Gachon University Gil Medical Center