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

• Sponsor: Gachon University Gil Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01871792
• Collaborator: Gangnam Severance Hospital (Other), Severance Hospital (Other), National Health Insurance Service Ilsan Hospital (Other), Myongji Hospital (Other), Bundang CHA Hospital (Other), Inje University (Other), Dankook University (Other), Eulji General Hospital (Other)
• Enrollment: 404
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 50.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contrast-induced Nephropathy	Drug: Pitavastatin; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 404 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Preventive Effect of the PRetreatment With pItavastatiN on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndErgoing Coronary Angiography/Intervention (PRINCIPLE-II Study)
• Study Start Date: Jun 1, 2013
• Anticipated Primary Completion Date: Feb 1, 2014
• Anticipated Study Completion Date: Feb 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Peak level of serum creatinine [48 hours]

   Peak level of serum creatinine within less than 48 hours after coronary angiography or intervention

2. 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

3. 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

4. Length of hospital stay [an expected average of 5 weeks]

5. Clinical events [1 month]

   Composites of death, myocardial infarction, stroke or need for dialysis therapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gachon University Gil Hospital	Incheon		Korea, Republic of	405-760

Sponsors and Collaborators

• Gachon University Gil Medical Center
• Gangnam Severance Hospital
• Severance Hospital
• National Health Insurance Service Ilsan Hospital
• Myongji Hospital
• Bundang CHA Hospital
• Inje University
• Dankook University
• Eulji General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Woong Chol Kang, Associate Professor, Gachon University Gil Medical Center
• ClinicalTrials.gov Identifier: NCT01871792
• Other Study ID Numbers: PRINCIPLE-II
• First Posted: Jun 7, 2013
• Last Update Posted: Jun 7, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Woong Chol Kang, Associate Professor, Gachon University Gil Medical Center: Contrast-induced nephropathy; Prevention; Statin; Pitavastatin
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency; Pitavastatin

Study Results

No Results Posted as of Jun 7, 2013