NCT01871792

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 404 (estimated)
• Sponsor: Gachon University Gil Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Pitavastatin
DRUG	Placebo	Sugar pill manufactured to mimic Pitavastatin 4 mg tablet

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-06-07
• Last updated: 2013-06-07

Locations

1 site across 1 country: South Korea