Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study)
1 other identifier
interventional
173
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 8, 2010
CompletedFirst Posted
Study publicly available on registry
April 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFebruary 6, 2012
February 1, 2012
1.3 years
April 8, 2010
February 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of contrast-induced nephropathy defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl
at 24 hours
Study Arms (2)
Nicorandil in saline
EXPERIMENTALsaline
PLACEBO COMPARATORInterventions
* 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yonsei Universitylead
- GE Healthcarecollaborator
Study Sites (1)
Severance Hospital
Seoul, 120-752, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young-Guk Ko, MD
Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2010
First Posted
April 14, 2010
Study Start
March 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
February 6, 2012
Record last verified: 2012-02