Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study)

Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study): A Investigator-initiated, Control- Randomized, Phase IV Multicenter Study

Renal hypoxia plays an important role in the development of contrast-induced nephropathy. The purpose of the PRINCIPLE study is to investigate the effect of pretreatment with intravenous nicorandil on the incidence of contrast-induced nephropathy in patients with renal insufficiency undergoing coronary angiography.

Inclusion Criteria:

• Patients aged ≥ 20 years
• Patients undergoing elective coronary angiogram due to documented myocardial ischemia or symptoms of angina
• Estimated Cr clearance ≤60 mL/min by Cockcroft-Gault formula or serum Cr ≥1.1 mg/dL
• Signed written informed consent to participate in the study

Exclusion Criteria:

• Acute myocardial infarction requiring primary or rescue coronary intervention
• Allergic reaction to contrast dye or nicorandil
• Cardiogenic shock or significant hypotension
• Previous use of nicorandil within the preceding 7 days
• Exposure to contrast medium within the preceding 7 days
• Pregnancy or women at age of childbearing potential
• Heart failure (NYHA class III or IV; LV ejection fraction <40% by echocardiogram)
• Acute renal failure or chronic dialysis
• Mechanical ventilation
• History of kidney transplantation
• Life expectation less than 6 months
• Previous renal artery angioplasty within the last 6 months
• Use of nonsteroidal anti-inflammatory drugs, intravenous use of diuretics, dopamine, mannitol, N-acetylcysteine, ascorbic acid or sodium bicarbonate within 48 hrs before the procedure
• Severe liver disease