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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)

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01103336
First received: April 8, 2010
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Chronic Renal Failure
 Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Incidence of contrast-induced nephropathy defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl [ Time Frame: at 24 hours ] [ Designated as safety issue: No ]

Enrollment: 173
Study Start Date: March 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103336

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
GE Healthcare
Investigators
Principal Investigator: Young-Guk Ko, MD Severance Hospital
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01103336     History of Changes
Other Study ID Numbers: 4-2009-0722
Study First Received: April 8, 2010
Last Updated: February 2, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Patients with chronic renal failure undergoing coronary angiography

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Nicorandil
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Antihypertensive Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013