Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT06738758
Status:
RECRUITING
Last Update Posted:
2025-03-17
First Post:
2024-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients(ELITE-ACS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-13', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The correlation between LDL-C in-hospital compliance, 1-month compliance, and 3-month compliance with MACE', 'timeFrame': "At hospital discharge, which is expected to occur between 5 to 10days after admission, depending on the patient's clinical progress; At 1, 3, 6, 12 months after discharge"}, {'measure': 'The correlation between the duration of LDL-C within the target and MACE', 'timeFrame': '12 months'}, {'measure': 'The correlation between different baseline GRACE score levels (low, medium, high) and MACE', 'timeFrame': '12 months'}, {'measure': 'The correlation between different baseline inflammatory cytokine level groups (quartiles) and MACE', 'timeFrame': '12 months'}, {'measure': 'The correlation between different baseline age groups (≤ 45 years old or not) and MACE', 'timeFrame': '12 months'}, {'measure': 'Percentage change in FAI measured by cardiac CT in patients undergoing elective PCI', 'timeFrame': '12 months', 'description': 'FAI is a quantitative indicator of inflammation in perivascular adipose tissue measured by CCTA.'}], 'primaryOutcomes': [{'measure': 'Lipid attainment rate at each visit node during the observation period (<1.4 mmol/L)', 'timeFrame': "3 days of medication; At hospital discharge, which is expected to occur between 5 to 10days after admission, depending on the patient's clinical progress; At 1, 3, 6, 12 months after discharge", 'description': 'Lipid attainment rate at each visit node during the observation period (\\<1.4 mmol/L)'}], 'secondaryOutcomes': [{'measure': 'The average time for different treatment groups to reach the guideline-recommended lipid standards (<1.4mmol/L) during the observation period.', 'timeFrame': "3 days of medication; At hospital discharge, which is expected to occur between 5 to 10days after admission, depending on the patient's clinical progress; At 1, 3, 6, 12 months after discharge", 'description': 'The average time for different treatment groups to reach the guideline-recommended lipid standards (\\<1.4mmol/L) during the observation period.'}, {'measure': 'The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups', 'timeFrame': '12 months', 'description': 'Description: MACEs was defined as the composite of myocardial infarction, ischemic stroke, cardiovascular death and coronary revascularization'}, {'measure': 'Time from in-hospital initiation of lipid-lowering therapy to first occurrence of any of the above clinical events', 'timeFrame': '12 months'}, {'measure': 'Percentage change from baseline in LDL-C across treatment groups at different visit nodes', 'timeFrame': "3 days of medication; At hospital discharge, which is expected to occur between 5 to 10days after admission, depending on the patient's clinical progress; At 1, 3, 6, 12 months after discharge"}, {'measure': 'Change from baseline in inflammatory factors', 'timeFrame': "3 days of medication; At hospital discharge, which is expected to occur between 5 to 10days after admission, depending on the patient's clinical progress; At 1, 3, 6, 12 months after discharge", 'description': 'Inflammatory factors include IL-6, CRP/Hypersensitive CRP'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Coronary Syndromes', 'PCSK9 Inhibitor', 'Lipid compliance time and rate', 'First cardiovascular event'], 'conditions': ['Acute Coronary Syndromes']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to evaluate the impact of early initiation of PCSK9 inhibitor therapy for intensive lipid-lowering in Chinese patients with acute coronary syndrome (ACS) during hospitalization on the rate of lipid goal attainment, the time to achieve guideline-recommended lipid levels within one year, and the incidence of adverse cardiovascular events.\n\nThe primary research question is whether early initiation of PCSK9 inhibitor therapy during hospitalization for ACS patients in a real-world Chinese setting can increase the rate of lipid goal attainment, shorten the time to reach guideline-recommended lipid levels within one year, and improve the risk of adverse cardiovascular events.\n\nResearchers will compare three lipid-lowering strategies: PCSK9 inhibitor therapy (with or without statins ± Ezetimibe/Hybutimibe), statin plus Ezetimibe/Hybutimibe therapy, and statin monotherapy, to assess the potential of PCSK9 inhibitor drugs in accelerating lipid goal achievement and reducing adverse cardiovascular events in ACS patients.\n\nParticipants will:\n\nReceive PCSK9 inhibitor therapy (with or without daily statins ± Ezetimibe/Hybutimibe) every two weeks, or daily statin plus Ezetimibe/Hybutimibe therapy, or daily statin monotherapy.\n\nUndergo follow-up assessments of relevant laboratory indicators at baseline, 3 days after admission, discharge, and 1, 3, 6, and 12 months post-discharge.\n\nRecord the occurrence of major adverse cardiovascular events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized for acute coronary syndrome (ACS). ACS is defined as STEMI, NSTEMI, and UA, where UA must be classified as high-risk in the GRACE score.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. This hospitalization for ACS, which includes ST-segment elevation MI (STEMI), non-ST-segment elevation MI (NSTEMI), or unstable angina pectoris (UA) with a GRACE score of intermediate to high risk.\n3. Written informed consent must be obtained from eligible patients prior to study enrollment.\n4. LDL-C ≥1.8 mmol/L in patients using statin; LDL-C ≥2.6 mmol/L in those not taking statin in the last 4 weeks.\n\nExclusion Criteria:\n\n1. Received PCSK9 inhibitor therapy within 3 months.\n2. Patient has any life-threatening severe disease, including severe liver injury and persistent elevation of serum transaminases, and severe renal failure.\n3. Patient has a history of renal or cardiac transplantation.\n4. The patient is a pregnant or breastfeeding woman or a woman planning to become pregnant.\n\nPatients judged by the investigator to be unsuitable for enrollment.'}, 'identificationModule': {'nctId': 'NCT06738758', 'acronym': 'ELITE-ACS', 'briefTitle': 'Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients(ELITE-ACS)', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients', 'orgStudyIdInfo': {'id': 'ELITE-ACS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intensive treatment group', 'description': 'patients were treated with PCSK9 inhibitors (with or without statins ± Ezetimibe/Hybutimibe)', 'interventionNames': ['Drug: PCSK9 inhibitor']}, {'label': 'Conventional combination therapy group', 'description': 'patients were treated with statin＋Ezetimibe/Hybutimibe', 'interventionNames': ['Drug: Statin+Ezetimibe/Hybutimibe compound']}, {'label': 'control group', 'description': 'patients were treated with statin only', 'interventionNames': ['Drug: Statin']}], 'interventions': [{'name': 'PCSK9 inhibitor', 'type': 'DRUG', 'description': "The patient used PCSK9 inhibitor (with or without statins ± Ezetimibe/Hybutimibe) in the early hospitalization, and patients continually prescribed or stopped PCSK9 inhibitors treatment during the follow-up visit, which depend on physician's clinical decision and patient preference. PCSK9 inhibitors include Evolocumab, Alirocumab, Tafolecimab, Recaticimab, and Inclisiran, among others.", 'armGroupLabels': ['Intensive treatment group']}, {'name': 'Statin+Ezetimibe/Hybutimibe compound', 'type': 'DRUG', 'description': "The patient used statins and Ezetimibe/Hybutimibe in early hospitalization, and then once a day for 12 months. Whether to adjust the lipid-lowering regimen during follow-up depends on physician's clinical decision and patient preference.", 'armGroupLabels': ['Conventional combination therapy group']}, {'name': 'Statin', 'type': 'DRUG', 'description': "The patient used statins in early hospitalization, and then once a day for 12 months. Whether to adjust the lipid-lowering regimen during follow-up depends on physician's clinical decision and patient preference.", 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dandan Li', 'role': 'CONTACT', 'email': 'lidandan5564@163.com', 'phone': '8613810545564'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Dandan Li, professor', 'role': 'CONTACT', 'email': 'lidandan5564@163.com', 'phone': '8613810545564'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yun Dai Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Yun Dai Chen', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}