Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-02-24 @ 6:25 PM
Study NCT ID:
NCT06730802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-12
First Post:
2024-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protective Effect of PCSK9 Inhibitor Against Negative Inflammatory Response and Organ Dysfunction After Coronary Artery Bypass Grafting (PANDA VIII)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2024-12-09', 'studyFirstSubmitQcDate': '2024-12-09', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiovascular and Cerebrovascular Events', 'timeFrame': '6 months after surgery', 'description': 'Major Adverse Cardiovascular and Cerebrovascular Events include cardiac death, reinfarction, emergency coronary revascularization and stroke'}], 'secondaryOutcomes': [{'measure': 'C-reactive protein', 'timeFrame': '6 months after surgery', 'description': 'Peripheral blood C-reactive protein'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inflammation', 'CABG'], 'conditions': ['Myocardial Ischaemic Syndrome', 'Coronary Heart Disease']}, 'referencesModule': {'references': [{'pmid': '33197560', 'type': 'BACKGROUND', 'citation': 'Oyama K, Furtado RHM, Fagundes A Jr, Zelniker TA, Tang M, Kuder J, Murphy SA, Hamer A, Wang H, Keech AC, Giugliano RP, Sabatine MS, Bergmark BA. Effect of Evolocumab on Complex Coronary Disease Requiring Revascularization. J Am Coll Cardiol. 2021 Jan 26;77(3):259-267. doi: 10.1016/j.jacc.2020.11.011. Epub 2020 Nov 13.'}, {'pmid': '35606883', 'type': 'BACKGROUND', 'citation': 'Na HR, Kwon OS, Kang JK, Kim YH, Lim JY. Evolocumab administration prior to Coronary Artery Bypass Grafting in patients with multivessel coronary artery disease (EVOCABG): study protocol for a randomized controlled clinical trial. Trials. 2022 May 23;23(1):430. doi: 10.1186/s13063-022-06398-3.'}, {'pmid': '38337601', 'type': 'BACKGROUND', 'citation': 'Nasso G, Larosa C, Bartolomucci F, Brigiani MS, Contegiacomo G, Demola MA, Vignaroli W, Tripoli A, Girasoli C, Lisco R, Trivigno M, Tunzi RM, Loizzo T, Hila D, Franchino R, Amodeo V, Ventra S, Diaferia G, Schinco G, Agro FE, Zingaro M, Rosa I, Lorusso R, Del Prete A, Santarpino G, Speziale G. Safety and Efficacy of PCSK9 Inhibitors in Patients with Acute Coronary Syndrome Who Underwent Coronary Artery Bypass Grafts: A Comparative Retrospective Analysis. J Clin Med. 2024 Feb 4;13(3):907. doi: 10.3390/jcm13030907.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized controlled study to investigate whether early offering PCSK9 inhibitor can protect against negative inflammatory response and organ dysfunction after coronary artery bypass grafting (CABG). Subjects with myocardial ischaemic syndromes (MIS) will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy, while the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later. Six month after CABG, CRP will be used to evaluate inflammation, and echocardiography and coronary CTA will be used to evaluate cardiovascular function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥ 18 years of age\n* Patients with myocardial ischemic syndromes (with any of the following):\n* Patients are ready to undergo coronary artery bypass grafting (CABG) with 1 month;\n* Participate voluntarily and sign an informed consent\n\nExclusion Criteria:\n\ni. Pregnant and lactating women ii. During the study period and within 3 months of receiving the last dose of the study drug, women with fertility intentions and men unwilling to use effective contraceptive methods iii. Have used PCSK9 inhibitors within 3 months before enrollment, or have a history of severe allergic reactions to PCSK9 inhibitors iv. Severe infections requiring intravenous antibiotics v. HIV-positive or history of acquired immunodeficiency syndrome (AIDS) vi. With cognitive impairment or psychiatric illnesses'}, 'identificationModule': {'nctId': 'NCT06730802', 'acronym': 'PANDA', 'briefTitle': 'Protective Effect of PCSK9 Inhibitor Against Negative Inflammatory Response and Organ Dysfunction After Coronary Artery Bypass Grafting (PANDA VIII)', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Protective Effect of PCSK9 Inhibitor Against Negative Inflammatory Response and Organ Dysfunction After Coronary Artery Bypass Grafting (PANDA VIII)', 'orgStudyIdInfo': {'id': 'PANDA VIII'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCSK9 inhibitor', 'description': 'the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later', 'interventionNames': ['Drug: PCSK9 inhibitor']}, {'type': 'SHAM_COMPARATOR', 'label': 'Statin', 'description': 'the control group will receive standard statin therapy.', 'interventionNames': ['Drug: Statin']}], 'interventions': [{'name': 'PCSK9 inhibitor', 'type': 'DRUG', 'description': 'the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later.', 'armGroupLabels': ['PCSK9 inhibitor']}, {'name': 'Statin', 'type': 'DRUG', 'description': 'the control group will receive standard statin therapy.', 'armGroupLabels': ['Statin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Hai-yang Li, MD', 'role': 'CONTACT', 'email': 'ocean0203@163.com'}, {'name': 'Hai-yang Li', 'role': 'CONTACT'}, {'name': 'Si-chong Qian, MD', 'role': 'CONTACT'}], 'facility': 'Beijing Anzhen Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Lu-yao Ma, MD', 'role': 'CONTACT', 'email': 'maluyao@jsph.org.cn', 'phone': '18801281613'}, {'name': 'Lu-yao Ma, MD', 'role': 'CONTACT', 'email': 'maluyao@jsph.org.cn', 'phone': '02568303101'}, {'name': 'Hong Liu', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Hong Liu, MD', 'role': 'CONTACT', 'email': 'dr.hongliu@foxmail.com', 'phone': '18801281613'}, {'name': 'Lu-yao Ma, MD', 'role': 'CONTACT', 'email': 'maluyao@jsph.org.cn', 'phone': '02568303101'}], 'overallOfficials': [{'name': 'Lu-yao Ma, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator of Department of Cardiovascular Surgery', 'investigatorFullName': 'Hong Liu', 'investigatorAffiliation': 'Nanjing Medical University'}}}}