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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:
ClinicalTrials.gov Identifier:
NCT01103336
First Posted: April 14, 2010
Last Update Posted: February 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Yonsei University
  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
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

Resource links provided by NLM:


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 ]

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

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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
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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01103336     History of Changes
Other Study ID Numbers: 4-2009-0722
First Submitted: April 8, 2010
First Posted: April 14, 2010
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:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Nicorandil
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs