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

Contrast-induced Nephropathy Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01871792
• Other study ID #: PRINCIPLE-II
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 25, 2013
• Last updated: June 4, 2013
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: June 2013
• Source: Gachon University Gil Medical Center
• Contact: Woong Chul Kang, M.D.
• Phone: +82-32-460-3663
• Email: kangwch[@]gilhospital.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 404
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast-induced Nephropathy
• Kidney Diseases
• Renal Insufficiency

Intervention

Drug:
• Pitavastatin

• Placebo
Sugar pill manufactured to mimic Pitavastatin 4 mg tablet

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Hospital	Incheon

Sponsors (9)

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Peak level of serum creatinine	Peak level of serum creatinine within less than 48 hours after coronary angiography or intervention	48 hours	No
Secondary	serum cystatin-C level	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	24 hours	No
Secondary	serum neutrophil-gelatinase-associated lipocalin(NGAL) level	Absolute level of serum NGAL level 4 hours after coronary angiography/intervention and difference level before and after coronary angiography/intervention	4 hours	No
Secondary	Length of hospital stay		an expected average of 5 weeks	No
Secondary	Clinical events	Composites of death, myocardial infarction, stroke or need for dialysis therapy	1 month	No