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

Phase 4

Completed

• Conditions: Chronic Renal Failure
• Interventions: Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography

• Registration Number: NCT01103336
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-14
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-02
• Last Update Posted: 2012-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicorandil in saline	pretreatment with intravenous nicorandil vs. placebo before coronary angiography	-
saline	pretreatment with intravenous nicorandil vs. placebo before coronary angiography	-

Primary Outcome Measures

Name	Time	Method
Incidence of contrast-induced nephropathy defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl	at 24 hours

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of