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

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ClinicalTrials.gov Identifier: NCT01871792
Recruitment Status : Unknown
Verified June 2013 by Woong Chol Kang, Gachon University Gil Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Sponsor:
Collaborators:
Gangnam Severance Hospital
Severance Hospital
National Health Insurance Service Ilsan Hospital
Myongji Hospital
Bundang CHA Hospital
Inje University
Dankook University
Eulji General Hospital
Information provided by (Responsible Party):
Woong Chol Kang, Gachon University Gil Medical Center

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pitavastatin
Pitavastatin 4 mg/day for 7 days before coronary angiography/intervention
 Drug: Pitavastatin
Other Name: 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
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Peak level of serum creatinine [ Time Frame: 48 hours ]
    Peak level of serum creatinine within less than 48 hours after coronary angiography or intervention

  2. 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

  3. 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. Length of hospital stay [ Time Frame: an expected average of 5 weeks ]
  5. Clinical events [ Time Frame: 1 month ]
    Composites of death, myocardial infarction, stroke or need for dialysis therapy


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871792


Contacts
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Contact: Woong Chul Kang, M.D. +82-32-460-3663 kangwch@gilhospital.com

Locations
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Korea, Republic of
Gachon University Gil Hospital
Incheon, Korea, Republic of, 405-760
Contact: Woong Chul Kang, M.D.    +82-32-460-3663    kangwch@gilhospital.com   
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
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Principal Investigator: Woong Chul Kang, M.D. Gachon University Gil Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Woong Chol Kang, Associate Professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01871792    
Other Study ID Numbers: PRINCIPLE-II
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013
Keywords provided by Woong Chol Kang, Gachon University Gil Medical Center:
Contrast-induced nephropathy
Prevention
Statin
Pitavastatin
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Urologic Diseases
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents