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

Chronic Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103336
• Other study ID #: 4-2009-0722
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2010
• Last updated: February 2, 2012
• Start date: March 2010
• Est. completion date: June 2011

Study information

• Verified date: February 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	GE Healthcare

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of contrast-induced nephropathy defined as an increase in serum creatinine =25% or =0.5 mg/dl		at 24 hours	No