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

Summary

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.

Conditions

• Contrast-induced Nephropathy

Interventions

DRUG

Pitavastatin

DRUG

Placebo

Sugar pill manufactured to mimic Pitavastatin 4 mg tablet

Sponsors & Collaborators

• Gangnam Severance Hospital

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• National Health Insurance Service Ilsan Hospital

  collaborator OTHER

• Myongji Hospital

  collaborator OTHER

• Bundang CHA Hospital

  collaborator OTHER

• Inje University

  collaborator OTHER

• Dankook University

  collaborator OTHER

• Eulji General Hospital

  collaborator OTHER

• Gachon University Gil Medical Center

  lead OTHER

Principal Investigators

• Woong Chul Kang, M.D. · Gachon University Gil Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2014-02-28

Completion

2014-02-28

Countries

• South Korea

Study Locations