Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT06338956
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2024-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimal Attained LDL-Cholesterol Levels in Patients Who Achieved ≥50% LDL Reduction After PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135877}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-17', 'studyFirstSubmitDate': '2024-03-24', 'studyFirstSubmitQcDate': '2024-03-24', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACCE', 'timeFrame': '10 years after PCI', 'description': 'major adverse cardiac and cerebrovascular events'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular death', 'timeFrame': '10 years after PCI', 'description': 'death from cardiovascular cause'}, {'measure': 'Spontaneous myocardial infarction', 'timeFrame': '10 years after PCI', 'description': 'MI with hospitalziation'}, {'measure': 'Repeat revascularization', 'timeFrame': '10 years after PCI', 'description': 'additional PCI or CABG'}, {'measure': 'Ischemic stroke', 'timeFrame': '10 years after PCI', 'description': 'Stoke from ischemic cause'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous coronary intervention', 'Statin'], 'conditions': ['Coronary Artery Disease', 'Hyperlipidemias']}, 'referencesModule': {'references': [{'pmid': '40294950', 'type': 'DERIVED', 'citation': 'Kang D, Choi KH, Yang S, Kim H, Park TK, Lee JM, Cho J, Yang JH, Song YB, Choi SH, Gwon HC, Hahn JY. Clinical significance of low-density lipoprotein cholesterol percentage reduction and attained levels after percutaneous coronary intervention. CMAJ. 2025 Apr 27;197(16):E442-E452. doi: 10.1503/cmaj.241713.'}]}, 'descriptionModule': {'briefSummary': 'For the management of low-density lipoprotein-cholesterol (LDL-C), some guidelines recommend initial statin treatment with high-intensity statins to achieve at least a 50% reduction in LDL-C levels. High-intensity or maximally tolerated intensity can be maintained without a target goal. However, the European guideline recommends less than 55 mg/dL of LDL-C after PCI.', 'detailedDescription': 'To investigate the Optimal Attained LDL-C Levels in Patients Who Achieved ≥50% LDL-C Reduction After PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery disease undergoing PCI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving PCI with health check up before and after PCI within 3 years\n\nExclusion Criteria:\n\n* Patients receiving statin before PCI\n* Patients with liver cirrhosis\n* Patients with cancer\n* Patients without prescription of statin\n* Patients with LDL-C \\<55 mg/dL before PCI'}, 'identificationModule': {'nctId': 'NCT06338956', 'acronym': 'Lipid-PCI', 'briefTitle': 'Optimal Attained LDL-Cholesterol Levels in Patients Who Achieved ≥50% LDL Reduction After PCI', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Optimal Attained LDL-Cholesterol Levels in Patients Who Achieved ≥50% LDL Reduction After PCI', 'orgStudyIdInfo': {'id': 'Lipid-PCI'}}, 'armsInterventionsModule': {'armGroups': [{'label': '>=50% LDL-C reduction', 'description': 'LDL-C reduction \\>=50%\n\nFurther divided by LDL \\<55mg/dL 55\\< LDL \\< 70 mg/dL LDL \\> 70 mg/dL', 'interventionNames': ['Drug: LDL reduction therapy']}, {'label': '<50% LDL-C reduction', 'description': 'LDL-C reduction \\<50%', 'interventionNames': ['Drug: LDL reduction therapy']}], 'interventions': [{'name': 'LDL reduction therapy', 'type': 'DRUG', 'description': 'LDL reduction therapy', 'armGroupLabels': ['<50% LDL-C reduction', '>=50% LDL-C reduction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ki Hong Choi', 'investigatorAffiliation': 'Samsung Medical Center'}}}}