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

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ClinicalTrials.gov Identifier: NCT01103336
Recruitment Status : Completed
First Posted : April 14, 2010
Last Update Posted : February 6, 2012
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Yonsei University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : March 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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Arms and Interventions
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Arm Intervention/treatment
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 Name: Nicorandil group versus Control group
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 Name: Nicorandil group versus Control group


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of contrast-induced nephropathy defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl [ Time Frame: at 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103336


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
GE Healthcare
Investigators
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Principal Investigator: Young-Guk Ko, MD Severance Hospital
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01103336    
Other Study ID Numbers: 4-2009-0722
First Posted: April 14, 2010    Key Record Dates
Last Update Posted: February 6, 2012
Last Verified: February 2012
Keywords provided by Yonsei University:
Patients with chronic renal failure undergoing coronary angiography
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Nicorandil
Anti-Arrhythmia Agents
Antihypertensive Agents
 Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs