Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Pitavastatin
Pitavastatin 4 mg/day for 7 days before coronary angiography/intervention
|
Drug: Pitavastatin
Other Name: Livalo® |
Placebo Comparator: Placebo
Placebo tablet for 7 days before coronary angiography/intervention
|
Drug: Placebo
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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. | +82-32-460-3663 | kangwch@gilhospital.com |
Korea, Republic of | |
Gachon University Gil Hospital | |
Incheon, Korea, Republic of, 405-760 | |
Contact: Woong Chul Kang, M.D. +82-32-460-3663 kangwch@gilhospital.com |
Principal Investigator: | Woong Chul Kang, M.D. | Gachon University Gil Medical Center |
Responsible Party: | Woong Chol Kang, Associate Professor, Gachon University Gil Medical Center |
ClinicalTrials.gov Identifier: | NCT01871792 |
Other Study ID Numbers: |
PRINCIPLE-II |
First Posted: | June 7, 2013 Key Record Dates |
Last Update Posted: | June 7, 2013 |
Last Verified: | June 2013 |
Contrast-induced nephropathy Prevention Statin Pitavastatin |
Kidney Diseases Renal Insufficiency Urologic Diseases Pitavastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents |