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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

Tracking Information
First Submitted Date  ICMJE May 25, 2013
First Posted Date  ICMJE June 7, 2013
Last Update Posted Date June 7, 2013
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
  • Peak level of serum creatinine [ Time Frame: 48 hours ]
    Peak level of serum creatinine within less than 48 hours after coronary angiography or intervention
  • 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
  • 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
  • Length of hospital stay [ Time Frame: an expected average of 5 weeks ]
  • Clinical events [ Time Frame: 1 month ]
    Composites of death, myocardial infarction, stroke or need for dialysis therapy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction
Official Title  ICMJE Preventive Effect of the PRetreatment With pItavastatiN on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndErgoing Coronary Angiography/Intervention (PRINCIPLE-II Study)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Contrast-induced Nephropathy
Intervention  ICMJE
  • Drug: Pitavastatin
    Other Name: Livalo®
  • Drug: Placebo
    Sugar pill manufactured to mimic Pitavastatin 4 mg tablet
Study Arms  ICMJE
  • Experimental: Pitavastatin
    Pitavastatin 4 mg/day for 7 days before coronary angiography/intervention
    Intervention: Drug: Pitavastatin
  • Placebo Comparator: Placebo
    Placebo tablet for 7 days before coronary angiography/intervention
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 4, 2013)
404
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2014
Estimated Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01871792
Other Study ID Numbers  ICMJE PRINCIPLE-II
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Woong Chol Kang, Gachon University Gil Medical Center
Study Sponsor  ICMJE Gachon University Gil Medical Center
Collaborators  ICMJE
  • Gangnam Severance Hospital
  • Severance Hospital
  • National Health Insurance Service Ilsan Hospital
  • Myongji Hospital
  • Bundang CHA Hospital
  • Inje University
  • Dankook University
  • Eulji General Hospital
Investigators  ICMJE
Principal Investigator: Woong Chul Kang, M.D. Gachon University Gil Medical Center
PRS Account Gachon University Gil Medical Center
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP