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

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Key information

Conditions

Chronic Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pretreatment with intravenous nicorandil vs. placebo before coronary angiography

Drug

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

Primary outcomes

Incidence of contrast-induced nephropathy defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl

Time frame: at 24 hours

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

GE Healthcare

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Apr 14, 2010
Registry last updated: Feb 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed