Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study)
NCT ID: NCT01103336
Last Updated: 2012-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
173 participants
INTERVENTIONAL
2010-03-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Nicorandil in saline
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
saline
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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GE Healthcare
INDUSTRY
Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Young-Guk Ko, MD
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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4-2009-0722
Identifier Type: -
Identifier Source: org_study_id
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