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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)

NCT01103336 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2012-02-06

No results posted yet for this study

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.

Conditions

  • Chronic Renal Failure

Interventions

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

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • Yonsei University

    lead OTHER

Principal Investigators

  • Young-Guk Ko, MD · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01103336 on ClinicalTrials.gov