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

Phase 4

• Conditions: Contrast-induced Nephropathy
• Interventions: Drug: Placebo; Drug: Pitavastatin

• Registration Number: NCT01871792
• Lead Sponsor: Gachon University Gil Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-25
• Status Verified: 2013-06
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-04
• Last Update Submitted: 2013-06-04
• Study First Posted: 2013-06-07
• Last Update Posted: 2013-06-07
• Primary Completion: 2014-02
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 404

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablet for 7 days before coronary angiography/intervention
Pitavastatin	Pitavastatin	Pitavastatin 4 mg/day for 7 days before coronary angiography/intervention

Primary Outcome Measures

Name	Time	Method
Incidence of contrast-induced nephropathy	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gachon University Gil Hospital; 🇰🇷 Incheon, Korea, Republic of