Clinical trial NCT01871792: Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Contrast-induced Nephropathy
Keywords: Contrast-induced nephropathy
Prevention
Statin
Pitavastatin
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
Collaborators: name: Gangnam Severance Hospital
name: Severance Hospital
name: National Health Insurance Service Ilsan Hospital
name: Myongji Hospital
name: Bundang CHA Hospital
name: Inje University
name: Dankook University
name: Eulji General Hospital
First posted: 2013-06-07
Enrollment: 404
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Incidence of contrast-induced nephropathy
timeFrame: 48 hours
Secondary outcomes:
measure: Peak level of serum creatinine
timeFrame: 48 hours
measure: serum cystatin-C level
timeFrame: 24 hours
measure: serum neutrophil-gelatinase-associated lipocalin(NGAL) level
timeFrame: 4 hours
measure: Length of hospital stay
timeFrame: an expected average of 5 weeks
measure: Clinical events
timeFrame: 1 month
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
Study officials:
affiliation: Gachon University Gil Medical Center
name: Woong Chul Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.