Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction

June 4, 2013 updated by: Woong Chol Kang, Gachon University Gil Medical Center

Preventive Effect of the PRetreatment With pItavastatiN on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndErgoing Coronary Angiography/Intervention (PRINCIPLE-II Study)

Contrast-induced nephropathy (CIN) is a well-recognized complication of radiographic contrast administration and is associated with increased short- and long-term mortality. Previous strategies including forced diuresis with diuretics or mannitol, intravenous administration of fenoldopam or dobutamine, and postprocedure hemodialysis to prevent CIN have been largely unsuccessful. In addition, the use of N-acetylcysteine to prevent CIN has yielded conflicting outcomes.

A review of a large insurance database and retrospective study have shown that statins therapy is associated with a lower incidence of CIN after percutaneous coronary intervention. The preventive effect of statins on CIN may be attributed to direct pleiotropic effects on the vascular wall such as improvement of endothelial dysfunction, anti-inflammatory or anti-oxidative effect. However, recent randomized trial could not demonstrate the preventive effect of statin on CIN in patients with chronic kidney disease.

Thus, we will investigate the preventive effect of pitavastatin on CIN in patient with renal dysfunction undergoing coronary angiography or intervention.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

404

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 19 years
  • Need for coronary angiography or intervention in patients with typical symptoms for angina or myocardial infarction, or documented myocardial ischemia at non-invasive studies including ECG, treadmill ECG test, heart spect or coronary CT angiography
  • Estimated glomerular filtration rate ≤60 mL/min
  • Informed consent

Exclusion Criteria:

  • Need for primary percutaneous coronary intervention or emergent intervention in patients with myocardial infarction
  • Allergic reaction for contrast agent (Visipaque) or statin
  • Contraindication for contrast agent (Visipaque) or statin
  • Shock status fron any cause including cardiogenic shock
  • Statin use before enrollment (Enrollment after 2 weeks of wash-out period)
  • Exposure of contrast agent within 7 days before enrollment
  • Pregnancy or Expectation for pregnancy in women of childbearing age
  • Heart failure (NYHA class ≥3 or left ventricular ejection fraction < 40%)
  • Acute renal injury
  • Dialysis therapy
  • Mechanical ventilator
  • Life expectancy < 6 months
  • Non-steroidal anti-inflammatory drug, dopamine, mannitol or N-acetylcysteine, ascorbic acid within 48 hours before and after coronary angiography/intervention
  • Severe hepatic dysfunction
  • Eisenmenger syndrome or idiopathic pulmonary hypertension
  • Renal artery angioplasty within 6 months
  • Single functioning kidney
  • Kidney transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pitavastatin
Pitavastatin 4 mg/day for 7 days before coronary angiography/intervention
Drug: Pitavastatin
Other Names:
  • Livalo®
Placebo Comparator: Placebo
Placebo tablet for 7 days before coronary angiography/intervention
Drug: Placebo
Sugar pill manufactured to mimic Pitavastatin 4 mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of contrast-induced nephropathy
Time Frame: 48 hours
Contrast-induced nephropathy is defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0.5 mg/dL after coronary angiography or intervention.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak level of serum creatinine
Time Frame: 48 hours
Peak level of serum creatinine within less than 48 hours after coronary angiography or intervention
48 hours
serum cystatin-C level
Time Frame: 24 hours
Absolute level of serum cystatin-C 24 hours after coronary angiography/intervention and Difference level of serum cystatin-C before and after coronary angiography/intervention
24 hours
serum neutrophil-gelatinase-associated lipocalin(NGAL) level
Time Frame: 4 hours
Absolute level of serum NGAL level 4 hours after coronary angiography/intervention and difference level before and after coronary angiography/intervention
4 hours
Length of hospital stay
Time Frame: an expected average of 5 weeks
an expected average of 5 weeks
Clinical events
Time Frame: 1 month
Composites of death, myocardial infarction, stroke or need for dialysis therapy
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Collaborators

Inje University
Gangnam Severance Hospital
Severance Hospital
Eulji General Hospital
Bundang CHA Hospital
Dankook University
National Health Insurance Service Ilsan Hospital
Myongji Hospital

Investigators

  • Principal Investigator: Woong Chul Kang, M.D., Gachon University Gil Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

May 25, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Estimate)

June 7, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRINCIPLE-II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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