Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study)
Primary Purpose
Chronic Renal Failure
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pretreatment with intravenous nicorandil vs. placebo before coronary angiography
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Renal Failure focused on measuring Patients with chronic renal failure undergoing coronary angiography
Eligibility 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
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nicorandil in saline
saline
Arm Description
Outcomes
Primary Outcome Measures
Incidence of contrast-induced nephropathy defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl
Secondary Outcome Measures
Full Information
NCT ID
NCT01103336
First Posted
April 8, 2010
Last Updated
February 2, 2012
Sponsor
Yonsei University
Collaborators
GE Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT01103336
Brief Title
Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
Collaborators
GE Healthcare
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
Keywords
Patients with chronic renal failure undergoing coronary angiography
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nicorandil in saline
Arm Type
Experimental
Arm Title
saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pretreatment with intravenous nicorandil vs. placebo before coronary angiography
Other Intervention Name(s)
Nicorandil group versus Control group
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of contrast-induced nephropathy defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl
Time Frame
at 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Guk Ko, MD
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study)
We'll reach out to this number within 24 hrs