Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-02-20 @ 10:09 PM
Study NCT ID:
NCT01265706
Status:
COMPLETED
Last Update Posted:
2014-12-15
First Post:
2010-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Livalo Acute Myocardial Infarction Study (LAMIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-12', 'studyFirstSubmitDate': '2010-10-18', 'studyFirstSubmitQcDate': '2010-12-22', 'lastUpdatePostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of TLR-MACE for 1 year after enrollment', 'timeFrame': '1 year after enrollment'}], 'secondaryOutcomes': [{'measure': 'Incidence of TVR-MACE for 1 year after enrollment', 'timeFrame': '1 year after enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hydroxymethylglutaryl-CoA Reductase Inhibitors'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'This study is performed to observe the incidence of major cardiovascular events in Korean patients with AMI after giving pitavastatin 2mg and 4mg longer than 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'AMI patients who are in need to be treated by statins', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with STEMI, NSTEMI\n* Patients satisfying at least one of the followings\n\n 1. Patients with LDL-C ≥ 130 mg/dL\n 2. Patients with LDL-C ≥ 100 mg/dL who are regarded as required cholesterol lowering therapy by the investigator\n 3. Patients taking statin are required continuous cholesterol lowering therapy\n* Patients satisfying at least two of the followings\n\n 1. The change of Ischemic ECG\n 2. CK, CK-MB, Troponin-I increased more than two times\n 3. The symptom of ACS\n\nExclusion Criteria:\n\n1. Patients with in-stent restenosis after PCI or coronary artery bypass\n2. Patients with cardiogenic shock\n3. Patients with severe heart failure (Left ventricular ejection fraction is less than 30%)\n4. Patients who are taking cyclosporine\n5. Patients who experienced hypersensitivity to pitavastatin\n6. Patients under dialysis treatment\n7. Patients who are participating other clinical trials\n8. Patients who can not stop taking concomitant drugs\n9. Pregnant or lactating women or suspected pregnancy\n10. Patients who are regarded as ineligible for this study by the investigator'}, 'identificationModule': {'nctId': 'NCT01265706', 'briefTitle': 'Livalo Acute Myocardial Infarction Study (LAMIS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'JW Pharmaceutical'}, 'officialTitle': '1-year, Prospective, Randomized, Open-label, Parallel Group Observational Study to Evaluate the Safety and Efficacy of 4mg/Day of Pitavastatin Versus 2mg/Day of Pitavastatin in Acute Myocardial Infarction(AMI)', 'orgStudyIdInfo': {'id': 'PTV_LAMIS II'}}, 'contactsLocationsModule': {'locations': [{'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}], 'overallOfficials': [{'name': 'Young Jun Hong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JW Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}