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| Name | Class |
|---|---|
| Gangnam Severance Hospital | OTHER |
| Severance Hospital | OTHER |
| National Health Insurance Service Ilsan Hospital | OTHER |
| Myongji Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin | Experimental | Pitavastatin 4 mg/day for 7 days before coronary angiography/intervention |
|
| Placebo | Placebo Comparator | Placebo tablet for 7 days before coronary angiography/intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak level of serum creatinine | Peak level of serum creatinine within less than 48 hours after coronary angiography or intervention | 48 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Woong Chul Kang, M.D. | Contact | +82-32-460-3663 | kangwch@gilhospital.com |
| Name | Affiliation | Role |
|---|---|---|
| Woong Chul Kang, M.D. | Gachon University Gil Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gachon University Gil Hospital | Incheon | 405-760 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33213012 | Derived | 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. |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
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| OTHER |
| Bundang CHA Hospital | OTHER |
| Inje University | OTHER |
| Dankook University | OTHER |
| Eulji General Hospital | OTHER |
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| Drug |
Sugar pill manufactured to mimic Pitavastatin 4 mg tablet |
|
| 24 hours |
| 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 |
| Length of hospital stay | an expected average of 5 weeks |
| Clinical events | Composites of death, myocardial infarction, stroke or need for dialysis therapy | 1 month |