Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study)
Status and phase
Completed
Phase 4
Conditions
Chronic Renal Failure
Treatments
Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography
Details and patient eligibility
About
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.
Enrollment
173 patients
Sex
All
Ages
20+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
173 participants in 2 patient groups, including a placebo group
Nicorandil in saline
Experimental group
Treatment:
Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography
saline
Placebo Comparator group
Treatment:
Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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