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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01103336

Enrollment

173

Registered

2010-04-14

Start date

2010-03-31

Completion date

2011-06-30

Last updated

2012-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure

Keywords

Patients with chronic renal failure undergoing coronary angiography

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.

Interventions

DRUGpretreatment 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026