Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT06567418
Status:
RECRUITING
Last Update Posted:
2024-08-22
First Post:
2024-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Analysis of the Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients
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': 'C571059', 'term': 'alirocumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2024-08-20', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Association between ACS pathway optimization participation and MACE within 1 year follow-up', 'timeFrame': '12 months', 'description': 'Association between ACS pathway optimization participation and MACE within 1 year follow-up'}, {'measure': 'Association between ACS pathway optimization participation and LDL-C goal attainment rate at 1-month follow-up', 'timeFrame': '1 month', 'description': 'Association between ACS pathway optimization participation and LDL-C goal attainment rate at 1-month follow-up'}, {'measure': 'Percentage reduction of LDL-C levels at 3-month, 6-month follow-up from baseline (if have enough follow-up data on lab test)', 'timeFrame': '3 months, 6 months', 'description': 'Percentage reduction of LDL-C levels at 3-month, 6-month follow-up from baseline (if have enough follow-up data on lab test)'}, {'measure': 'LDL-C goal attainment rate (<1.4mmol/L) at 3-month, 6-month follow-up (if have enough follow-up data on lab test)', 'timeFrame': '3 months, 6 months', 'description': 'LDL-C goal attainment rate (\\<1.4mmol/L) at 3-month, 6-month follow-up (if have enough follow-up data on lab test)'}], 'primaryOutcomes': [{'measure': 'The primary endpoint is the risk of MACE within 1 year of follow-up', 'timeFrame': '12 months', 'description': 'MACE was defined as the composite of non-fatal myocardial infarction, non-fatal ischemic stroke, all-cause mortality, or any coronary revascularization. Coronary revascularization was limited to procedures occurring at least two weeks after the index date, including PCI and CABG'}], 'secondaryOutcomes': [{'measure': 'Percentage reduction of LDL-C levels at 1-month follow-up from baseline', 'timeFrame': '1 month', 'description': 'Percentage reduction of LDL-C levels at 1-month follow-up from baseline'}, {'measure': 'Proportion of patient who achieved LDL-C goal (<1.4mmol/L) at 1-month follow-up', 'timeFrame': '1 month', 'description': 'Proportion of patient who achieved LDL-C goal (\\<1.4mmol/L) at 1-month follow-up'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the effectiveness of in-hospital initiation of alirocumab combined with statin ± ezetimibe on major cardiovascular events (MACE) in Chinese ACS patients. The main question it aims to answer is:\n\nwhether early initiation PCKS9i in hospital could reduce recent cardiovascular event risk in Chinese ACS patients in real-world setting.\n\nData from CCA Database-Chest Pain Center were screened for all ACS patients from 01-Jan 2021 to 31-Dec 2023. Patients diagnosed with STEMI, NSTEMI or UA at admission were identified at the first step. Then, for intervention group, patients who received alirocumab 75mg combined with statin ± ezetimibe during the ACS hospitalization (including the discharge date) will be included; for control group, patients who received statin ± ezetimibe during the ACS hospitalization will be included. All enrolled patients were required to have at least one documented follow-up visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Data from CCA Database-Chest Pain Center were screened for all ACS patients from 01-Jan 2021 to 31-Dec 2023. Patients diagnosed with STEMI, NSTEMI or UA at admission were identified at the first step. Then, for intervention group, patients who received alirocumab 75mg combined with statin ± ezetimibe during the ACS hospitalization (including the discharge date) will be included; for control group, patients who received statin ± ezetimibe during the ACS hospitalization will be included. All enrolled patients were required to have at least one documented follow-up visit. Patients prescribed with evolocumab at any time will be excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with Acute Coronary Syndrome (ACS) upon hospital admission.\n* Patients aged 18 years or older.\n* Patients who received Alirocumab 75 mg in combination with statin therapy ± Ezetimibe as the intervention group, and those treated exclusively with statin therapy ± Ezetimibe as the control group, either during hospitalization or at discharge.\n* Patients with at least one follow-up record.\n\nExclusion Criteria:\n\n* Patients who received Evolocumab treatment at any time.\n* Patients who received Inclisiran treatment at any time.'}, 'identificationModule': {'nctId': 'NCT06567418', 'briefTitle': 'Retrospective Analysis of the Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients: A Database-based Retrospective Analysis', 'orgStudyIdInfo': {'id': '2023ESR0000153'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'intervention group', 'description': 'patients were treated with alirocumab 75mg combined with statin ± ezetimibe', 'interventionNames': ['Drug: alirocumab 75mg/2week']}, {'label': 'control group', 'description': 'patients were treated with statin ± ezetimibe only', 'interventionNames': ['Drug: statin ± ezetimibe']}], 'interventions': [{'name': 'alirocumab 75mg/2week', 'type': 'DRUG', 'description': "patients continually prescribed or stopped alirocumab treatment during the follow-up visit, which depend on physician's clinical decision and patient preference", 'armGroupLabels': ['intervention group']}, {'name': 'statin ± ezetimibe', 'type': 'DRUG', 'description': 'patients will be censored at initiation of alirocumab during the follow up visit', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dandan Li, MD', 'role': 'CONTACT', 'email': 'lidandan5564@163.com', 'phone': '13810545564', 'phoneExt': '86'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Dandan Li, Dr.', 'role': 'CONTACT', 'email': 'lidandan5564@163.com', 'phone': '+86 13810545564'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yun Dai Chen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Yun Dai Chen', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}