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.

Study Overview

• Status: Completed
• Conditions: Chronic Renal Failure
• Intervention / Treatment: Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: saline	Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography; Nicorandil group: Pretreatment with intravenous Nicorandil (Sigmart for injection, Choongwae Pharma, Seoul) 12 mg in 0.9% saline 100 ml over 2 hours starting from 1 hour prior to coronary angiography; Control group: Pretreatment with intravenous 0.9% saline 100 ml over 2 hours starting from 1 hour prior to coronary angiography; Other Names: Nicorandil group versus Control group
EXPERIMENTAL: Nicorandil in saline	Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography; Nicorandil group: Pretreatment with intravenous Nicorandil (Sigmart for injection, Choongwae Pharma, Seoul) 12 mg in 0.9% saline 100 ml over 2 hours starting from 1 hour prior to coronary angiography; Control group: Pretreatment with intravenous 0.9% saline 100 ml over 2 hours starting from 1 hour prior to coronary angiography; Other Names: Nicorandil group versus Control group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Young-Guk Ko, MD, Severance Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: April 8, 2010
• First Submitted That Met QC Criteria: April 13, 2010
• First Posted (ESTIMATE): April 14, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 6, 2012
• Last Update Submitted That Met QC Criteria: February 2, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Patients with chronic renal failure undergoing coronary angiography
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Micronutrients; Vitamins; Vitamin B Complex; Nicorandil
• Other Study ID Numbers: 4-2009-0722