Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction

Gachon University Gil Medical Center

Status and phase: Unknown; Phase 4

Conditions: Contrast-induced Nephropathy

Treatments: Drug: Placebo; Drug: Pitavastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01871792

PRINCIPLE-II

Details and patient eligibility

About

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.

Enrollment: 404 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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404 participants in 2 patient groups, including a placebo group

Pitavastatin

Experimental group

Description:

Pitavastatin 4 mg/day for 7 days before coronary angiography/intervention

Treatment:

Drug: Pitavastatin

Placebo

Placebo Comparator group

Description:

Placebo tablet for 7 days before coronary angiography/intervention

Treatment:

Drug: Placebo