Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT00786734
Status:
WITHDRAWN
Last Update Posted:
2012-03-30
First Post:
2008-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pitavastatin Pre-Treatment Study in Patient With Elective PCI for Stable Angina Pectoris (PIPA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108475', 'term': 'pitavastatin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-28', 'studyFirstSubmitDate': '2008-11-05', 'studyFirstSubmitQcDate': '2008-11-05', 'lastUpdatePostDateStruct': {'date': '2012-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients whose CK-MB > 2 times above UNL', 'timeFrame': 'First evaulation time (before PCI)'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients who show any increase of CK-MB, troponin I, and myoglobin above UNL', 'timeFrame': 'First evaluation time'}, {'measure': 'Mean peak values of CK-MB, troponin I and myoglobin after intervention', 'timeFrame': 'After PCI (<24hrs)'}, {'measure': 'Change of hs-CRP, wall motion score', 'timeFrame': 'Second evaluation time'}, {'measure': 'Occurence of all major adverse cardiac events', 'timeFrame': 'Second evaluation time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pitavastatin', 'PCI', 'stable angina'], 'conditions': ['Percutaneous Coronary Intervention']}, 'descriptionModule': {'briefSummary': 'Patients who is scheduled elective PCI are randomized to pitavastatin 4mg daily or without pitavastatin for 5 -7days before the procedure. Creatine kinase-MB, troponin I, and myoglobin levels are measured at baseline and at 8 and 24 hours after the procedure(1st evaluation). After PCI, pitavastatin will be administered for additional 4 weeks(2nd evaluation).', 'detailedDescription': 'Procedural ischemic myocardial injury remains the most frequent complication after coronary angioplasty. Recently it was reported that pretreatment with atorvastatin reduce the myocardial damage compared to placebo. Thus, we will evaluate the difference of pretreatment of pitavastatin compared to standard therapy on the reduction of myocardial damage in patient who is scheduled elective PCI for stable angina pectoris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with LDL ≥ 100mg/dL\n* Patients who are scheduled an elective PCI for stable angina\n\nExclusion Criteria:\n\n* Acute myocardial infarction (\\<3 months)\n* Unstable angina\n* Previous treatment with statins (\\<6 months)\n* Increase in CK-MB above upper normal limit\n* Increase in liver enzymes (AST/ALT) above 2 times of upper normal limit\n* Increase in serum creatinine above 2 times of upper normal limit\n* Left ventricular ejection fraction \\<30%\n* Previous treatment with glycoprotein Ⅱb/Ⅲa receptor inhibitor (\\<4 weeks)'}, 'identificationModule': {'nctId': 'NCT00786734', 'briefTitle': 'Pitavastatin Pre-Treatment Study in Patient With Elective PCI for Stable Angina Pectoris (PIPA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'JW Pharmaceutical'}, 'officialTitle': 'A Randomized, Open Label, Comparative Study to Evaluate Effect of Pitavastatin for Reduction of Myocardial Damage in Patient Are Scheduled Elective PCI for Stable Angina Pectoris', 'orgStudyIdInfo': {'id': 'CWP-PTV-705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pitavastatin Group', 'interventionNames': ['Drug: Pitavastatin']}, {'type': 'OTHER', 'label': 'Usual Care Group', 'interventionNames': ['Drug: Pitavastatin']}], 'interventions': [{'name': 'Pitavastatin', 'type': 'DRUG', 'description': '4mg daily for 5-7 days before Percutaneous Coronary Intervention(PCI) and 4mg daily for 28 days after PCI', 'armGroupLabels': ['Pitavastatin Group']}, {'name': 'Pitavastatin', 'type': 'DRUG', 'description': '4mg daily for 28 days after PCI', 'armGroupLabels': ['Usual Care Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': "Catholic University of Korea Kangnam St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Ki Bae Seung, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Professor, Catholic University of Korea Kangnam St. Mary's Hospital located"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JW Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}