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

Study Overview
=================
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.

Official 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

Conditions
-----------------
Chronic Renal Failure

Intervention / Treatment
-----------------
* Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicorandil in saline<br> | Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography<br>* 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<br>* Other names: Nicorandil group versus Control group;|
| Placebo Comparator: saline<br> | Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography<br>* 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<br>* Other names: Nicorandil group versus Control group;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with chronic renal failure undergoing coronary angiography