Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-24 @ 4:59 PM
Study NCT ID:
NCT05292404
Status:
RECRUITING
Last Update Posted:
2024-12-20
First Post:
2022-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C571059', 'term': 'alirocumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'PCSK9 inhibitor'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2022-03-13', 'studyFirstSubmitQcDate': '2022-03-21', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'myocardial salvage index', 'timeFrame': '1 week after operation', 'description': 'measured by Magnetic Resonance Imaging (MRI)'}], 'secondaryOutcomes': [{'measure': 'Eject fraction', 'timeFrame': 'at 6 months after operation', 'description': 'measured by MRI'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '36211588', 'type': 'DERIVED', 'citation': 'Xia J, Wang X, Zhou J, Wang D, Pang Y, Xu X, Sang Z, Zhang Y, Zhang J, Wu S, Xiao Z, Hou L. Impact of early PCSK9 inhibitor treatment on heart after percutaneous coronary intervention in patients with STEMI: Design and rationale of the PERFECT II trial. Front Cardiovasc Med. 2022 Sep 23;9:1009674. doi: 10.3389/fcvm.2022.1009674. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, prospective, randomized, controlled study. The patients with STEMI who were to undergo PPCI were divided into PCSK9 inhibitor group (n=80) and conventional treatment group (n=80) using the interactive web response system (IWRS), at a 1:1 ratio. In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months; the control group received conventional treatment. Cardiac Magnetic Resonance Imaging (MRI) were used to measure myocardial salvage index at 1 week after operation as primary endpoints. Eject fraction at 6 months after operation will also be measured by MRI as secondary endpoints. Serum TnI/T，CKMB levels were detected q8h for three times and and LDL-C levels were detected at 1 month, 3 months and 6 months after operation. Blood inflammation indicators were detected before and 1 week after the operation, and 6 months after the operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The age is greater than 18 years old and less than or equal to 80 years old.\n2. Patients who are clinically diagnosed with STEMI onset within 24 hours and who are planning to undergo PPCI .\n3. Signed informed consent.\n\nExclusion Criteria:\n\n1. Patients who are allergic to PCSK9 inhibitors.\n2. Multivessel disease planned for selective intervention within half a year.\n3. Patients who have previously undergone revascularization.\n4. Pregnant women or women who plan to become pregnant in the next 2 years.\n5. Patients whose life expectancy is less than 1 year.\n6. Severe liver or kidney dysfunction (ALT\\>5 times ULA, eGFR\\<15ml/min/1.73m2)\n7. Known active malignant tumor diseases.\n8. Patients considered by the investigator to be unsuitable to participate in this study.'}, 'identificationModule': {'nctId': 'NCT05292404', 'briefTitle': 'Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Tong Ren Hospital'}, 'officialTitle': 'Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction： a Muti-center, Open-label, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ShanghaiTRH-HL2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early PCSK9 inhibitor treatment group', 'interventionNames': ['Drug: alirocumab']}, {'type': 'OTHER', 'label': 'conventional treatment group', 'interventionNames': ['Other: conventional treatment']}], 'interventions': [{'name': 'alirocumab', 'type': 'DRUG', 'description': 'In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab,75mg) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months', 'armGroupLabels': ['Early PCSK9 inhibitor treatment group']}, {'name': 'conventional treatment', 'type': 'OTHER', 'description': 'conventional treatment were given according to international uniformguidelines', 'armGroupLabels': ['conventional treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200050', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junfeng Zhang, doctor', 'role': 'CONTACT'}], 'facility': "nineth people's hospital, School of Medicine, shanghai jiaotong university", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200050', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhenchi sang, doctor', 'role': 'CONTACT'}], 'facility': 'Shanghai chest hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200050', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Hou, doctor', 'role': 'CONTACT', 'email': 'Dr_houlei@163.com'}, {'name': 'Lei Hou, doctor', 'role': 'CONTACT'}], 'facility': 'Shanghai tongren hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200050', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Zhang, doctor', 'role': 'CONTACT'}], 'facility': "tenth people's hospital, tongji university, Shanghai", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tongqing Yao, doc', 'role': 'CONTACT'}], 'facility': 'Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Lei Hou, doctor', 'role': 'CONTACT', 'email': 'Dr_houlei@163.com', 'phone': '86-13564868096'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Tong Ren Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'China Cardiovascular Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hou Lei', 'investigatorAffiliation': 'Shanghai Tong Ren Hospital'}}}}