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

Primary Purpose

Contrast-induced Nephropathy

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Pitavastatin

Placebo

About this trial

This is an interventional prevention trial for Contrast-induced Nephropathy focused on measuring Contrast-induced nephropathy, Prevention, Statin, Pitavastatin

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gachon University Gil Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pitavastatin

Placebo

Arm Description

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

Placebo tablet for 7 days before coronary angiography/intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Peak level of serum creatinine

Peak level of serum creatinine within less than 48 hours after coronary angiography or intervention

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

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

Length of hospital stay

Clinical events

Composites of death, myocardial infarction, stroke or need for dialysis therapy

Full Information

NCT ID

NCT01871792

First Posted

May 25, 2013

Last Updated

June 4, 2013

Sponsor

Gachon University Gil Medical Center

Collaborators

Gangnam Severance Hospital, Severance Hospital, National Health Insurance Service Ilsan Hospital, Myongji Hospital, Bundang CHA Hospital, Inje University, Dankook University, Eulji General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01871792

Brief Title

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

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Unknown status

Study Start Date

June 2013 (undefined)

Primary Completion Date

February 2014 (Anticipated)

Study Completion Date

February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gachon University Gil Medical Center

Collaborators

Gangnam Severance Hospital, Severance Hospital, National Health Insurance Service Ilsan Hospital, Myongji Hospital, Bundang CHA Hospital, Inje University, Dankook University, Eulji General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Contrast-induced Nephropathy

Keywords

Contrast-induced nephropathy, Prevention, Statin, Pitavastatin

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

404 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pitavastatin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablet for 7 days before coronary angiography/intervention

Intervention Type

Drug

Intervention Name(s)

Pitavastatin

Other Intervention Name(s)

Livalo®

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Sugar pill manufactured to mimic Pitavastatin 4 mg tablet

Primary Outcome Measure Information:

Title

Incidence of contrast-induced nephropathy

Description

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.

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Peak level of serum creatinine

Description

Peak level of serum creatinine within less than 48 hours after coronary angiography or intervention

Time Frame

48 hours

Title

serum cystatin-C level

Description

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

Time Frame

24 hours

Title

serum neutrophil-gelatinase-associated lipocalin(NGAL) level

Description

Absolute level of serum NGAL level 4 hours after coronary angiography/intervention and difference level before and after coronary angiography/intervention

Time Frame

4 hours

Title

Length of hospital stay

Time Frame

an expected average of 5 weeks

Title

Clinical events

Description

Composites of death, myocardial infarction, stroke or need for dialysis therapy

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Woong Chul Kang, M.D.

Phone

+82-32-460-3663

kangwch@gilhospital.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Woong Chul Kang, M.D.

Organizational Affiliation

Gachon University Gil Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gachon University Gil Hospital

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Woong Chul Kang, M.D.

Phone

+82-32-460-3663

kangwch@gilhospital.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

33213012

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.

Results Reference

derived

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

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