Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-03-12 @ 1:13 AM
Study NCT ID:
NCT01871792
Status:
UNKNOWN
Last Update Posted:
2013-06-07
First Post:
2013-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C108475', 'term': 'pitavastatin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 404}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-04', 'studyFirstSubmitDate': '2013-05-25', 'studyFirstSubmitQcDate': '2013-06-04', 'lastUpdatePostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of contrast-induced nephropathy', 'timeFrame': '48 hours', '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.'}], 'secondaryOutcomes': [{'measure': 'Peak level of serum creatinine', 'timeFrame': '48 hours', 'description': 'Peak level of serum creatinine within less than 48 hours after coronary angiography or intervention'}, {'measure': 'serum cystatin-C level', 'timeFrame': '24 hours', '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'}, {'measure': 'serum neutrophil-gelatinase-associated lipocalin(NGAL) level', 'timeFrame': '4 hours', 'description': 'Absolute level of serum NGAL level 4 hours after coronary angiography/intervention and difference level before and after coronary angiography/intervention'}, {'measure': 'Length of hospital stay', 'timeFrame': 'an expected average of 5 weeks'}, {'measure': 'Clinical events', 'timeFrame': '1 month', 'description': 'Composites of death, myocardial infarction, stroke or need for dialysis therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Contrast-induced nephropathy', 'Prevention', 'Statin', 'Pitavastatin'], 'conditions': ['Contrast-induced Nephropathy']}, 'referencesModule': {'references': [{'pmid': '33213012', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nA 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.\n\nThus, we will investigate the preventive effect of pitavastatin on CIN in patient with renal dysfunction undergoing coronary angiography or intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 19 years\n* 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\n* Estimated glomerular filtration rate ≤60 mL/min\n* Informed consent\n\nExclusion Criteria:\n\n* Need for primary percutaneous coronary intervention or emergent intervention in patients with myocardial infarction\n* Allergic reaction for contrast agent (Visipaque) or statin\n* Contraindication for contrast agent (Visipaque) or statin\n* Shock status fron any cause including cardiogenic shock\n* Statin use before enrollment (Enrollment after 2 weeks of wash-out period)\n* Exposure of contrast agent within 7 days before enrollment\n* Pregnancy or Expectation for pregnancy in women of childbearing age\n* Heart failure (NYHA class ≥3 or left ventricular ejection fraction \\< 40%)\n* Acute renal injury\n* Dialysis therapy\n* Mechanical ventilator\n* Life expectancy \\< 6 months\n* Non-steroidal anti-inflammatory drug, dopamine, mannitol or N-acetylcysteine, ascorbic acid within 48 hours before and after coronary angiography/intervention\n* Severe hepatic dysfunction\n* Eisenmenger syndrome or idiopathic pulmonary hypertension\n* Renal artery angioplasty within 6 months\n* Single functioning kidney\n* Kidney transplantation'}, 'identificationModule': {'nctId': 'NCT01871792', 'briefTitle': 'Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'Preventive Effect of the PRetreatment With pItavastatiN on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndErgoing Coronary Angiography/Intervention (PRINCIPLE-II Study)', 'orgStudyIdInfo': {'id': 'PRINCIPLE-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pitavastatin', 'description': 'Pitavastatin 4 mg/day for 7 days before coronary angiography/intervention', 'interventionNames': ['Drug: Pitavastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet for 7 days before coronary angiography/intervention', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pitavastatin', 'type': 'DRUG', 'otherNames': ['Livalo®'], 'armGroupLabels': ['Pitavastatin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sugar pill manufactured to mimic Pitavastatin 4 mg tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '405-760', 'city': 'Incheon', 'country': 'South Korea', 'contacts': [{'name': 'Woong Chul Kang, M.D.', 'role': 'CONTACT', 'email': 'kangwch@gilhospital.com', 'phone': '+82-32-460-3663'}], 'facility': 'Gachon University Gil Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'centralContacts': [{'name': 'Woong Chul Kang, M.D.', 'role': 'CONTACT', 'email': 'kangwch@gilhospital.com', 'phone': '+82-32-460-3663'}], 'overallOfficials': [{'name': 'Woong Chul Kang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gachon University Gil Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'National Health Insurance Service Ilsan Hospital', 'class': 'OTHER'}, {'name': 'Myongji Hospital', 'class': 'OTHER'}, {'name': 'Bundang CHA Hospital', 'class': 'OTHER'}, {'name': 'Inje University', 'class': 'OTHER'}, {'name': 'Dankook University', 'class': 'OTHER'}, {'name': 'Eulji General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Woong Chol Kang', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}