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

NCT01871792 | Unknown Phase 4 DMC

• 1 other identifier: PRINCIPLE-II
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast-induced Nephropathy

Keywords

Contrast-induced nephropathy; Prevention; Statin; Pitavastatin

Outcome Measures

Primary Outcomes (1)

• Incidence of contrast-induced nephropathy

  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.

  48 hours

Secondary Outcomes (5)

• Peak level of serum creatinine

  48 hours

• serum cystatin-C level

  24 hours

• serum neutrophil-gelatinase-associated lipocalin(NGAL) level

  4 hours

• Length of hospital stay

  an expected average of 5 weeks

• Clinical events

  1 month

Study Arms (2)

Pitavastatin

EXPERIMENTAL

Pitavastatin 4 mg/day for 7 days before coronary angiography/intervention

Drug: Pitavastatin

Placebo

PLACEBO COMPARATOR

Placebo tablet for 7 days before coronary angiography/intervention

Drug: Placebo

Interventions

Pitavastatin DRUG

Also known as: Livalo®

Pitavastatin

Placebo DRUG

Sugar pill manufactured to mimic Pitavastatin 4 mg tablet

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Gachon University Gil Hospital

Incheon, 405-760, South Korea

Location

Related Publications (1)

• Kang WC, Kim M, Park SM, Kim BK, Lee BK, Kwon HM. Preventive Effect of Pretreatment with Pitavastatin on Contrast-Induced Nephropathy in Patients with Renal Dysfunction Undergoing Coronary Procedure: PRINCIPLE-II Randomized Clinical Trial. J Clin Med. 2020 Nov 17;9(11):3689. doi: 10.3390/jcm9113689.

  PMID: 33213012 DERIVED

MeSH Terms

Interventions

pitavastatin

Study Officials

• Woong Chul Kang, M.D.

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Woong Chul Kang, M.D.

CONTACT

+82-32-460-3663; kangwch@gilhospital.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 25, 2013
• First Posted: June 7, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 7, 2013

Record last verified: 2013-06

Locations

KR (1)