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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014