Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction
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|ClinicalTrials.gov Identifier: NCT01871792|
Recruitment Status : Unknown
Verified June 2013 by Woong Chol Kang, Gachon University Gil Medical Center.
Recruitment status was: Not yet recruiting
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Contrast-induced Nephropathy||Drug: Pitavastatin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||404 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||June 2013|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||February 2014|
Pitavastatin 4 mg/day for 7 days before coronary angiography/intervention
Other Name: Livalo®
Placebo Comparator: Placebo
Placebo tablet for 7 days before coronary angiography/intervention
Sugar pill manufactured to mimic Pitavastatin 4 mg tablet
- Incidence of contrast-induced nephropathy [ Time Frame: 48 hours ]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.
- Peak level of serum creatinine [ Time Frame: 48 hours ]Peak level of serum creatinine within less than 48 hours after coronary angiography or intervention
- serum cystatin-C level [ Time Frame: 24 hours ]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 [ Time Frame: 4 hours ]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 [ Time Frame: an expected average of 5 weeks ]
- Clinical events [ Time Frame: 1 month ]Composites of death, myocardial infarction, stroke or need for dialysis therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871792
|Contact: Woong Chul Kang, M.D.||+firstname.lastname@example.org|
|Korea, Republic of|
|Gachon University Gil Hospital|
|Incheon, Korea, Republic of, 405-760|
|Contact: Woong Chul Kang, M.D. +82-32-460-3663 email@example.com|
|Principal Investigator:||Woong Chul Kang, M.D.||Gachon University Gil Medical Center|