Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-02 @ 5:31 AM
Study NCT ID:
NCT04851769
Status:
COMPLETED
Last Update Posted:
2021-04-20
First Post:
2021-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of PCSK9 Inhibitors on Coronary Plaque Composition and Vulnerability Assessed by Optical Coherence Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}, {'id': 'C571059', 'term': 'alirocumab'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-18', 'studyFirstSubmitDate': '2021-03-31', 'studyFirstSubmitQcDate': '2021-04-18', 'lastUpdatePostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'minimum fibrous-cap thickness', 'timeFrame': '36 weeks', 'description': 'The primary endpoint of the study is the OCT derived changes in minimum fibrous-cap thickness between baseline and follow-up.'}], 'secondaryOutcomes': [{'measure': 'minimum lumen area and maximum lipid arc', 'timeFrame': '36 weeks', 'description': 'Secondary endpoints include minimum lumen area between baseline and follow-up, as well as the absolute changes in maximum lipid arc.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Randomized Controlled Trials']}, 'referencesModule': {'references': [{'pmid': '35600486', 'type': 'DERIVED', 'citation': 'Gao F, Li YP, Ma XT, Wang ZJ, Shi DM, Zhou YJ. Effect of Alirocumab on Coronary Calcification in Patients With Coronary Artery Disease. Front Cardiovasc Med. 2022 May 6;9:907662. doi: 10.3389/fcvm.2022.907662. eCollection 2022.'}, {'pmid': '34511134', 'type': 'DERIVED', 'citation': 'Gao F, Wang ZJ, Ma XT, Shen H, Yang LX, Zhou YJ. Effect of alirocumab on coronary plaque in patients with coronary artery disease assessed by optical coherence tomography. Lipids Health Dis. 2021 Sep 12;20(1):106. doi: 10.1186/s12944-021-01528-3.'}]}, 'descriptionModule': {'briefSummary': 'The study is a prospective, open-label, randomized, single-center study involving patients with intermediate coronary lesions (50%-70% diameter stenosis) and who have elevated LDL-C values (LDL-C≥100 mg/dL) despite stable statin therapy.\n\nEligible patients are randomized to receive either alirocumab or standard-of-care (1:1). The last dose of alirocumab will be given at week 34. Patients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin 10mg/day). Patients in the standard-of-care arm will continue to receive atorvastatin 20 mg/day or rosuvastatin 10 mg/day. OCT images will be acquired at the baseline and at week 36 ± 2 weeks follow-up.', 'detailedDescription': 'The study is a prospective, open-label, randomized, single-center study involving patients with intermediate coronary lesions (50%-70% diameter stenosis) and who have elevated LDL-C values (LDL-C≥100 mg/dL) despite stable statin therapy.\n\nEligible patients included those who are (I) at least 18 years of age, (II) diagnosed as stable coronary artery disease or acute coronary syndrome during admission (III) undergoing clinically indicated coronary angiography and identified with at least one intermediate lesion (50%-70% diameter stenosis) on de novo coronary arteries, (IV) have an elevated LDL-C values (LDL-C≥100 mg/dL) despite taken rosuvastatin 10 mg/day or atorvastatin 20 mg/day for 2-4 weeks after initiation or with maximally tolerated statin therapy, (V) able to provide written, informed consent.\n\nThe study included a 36-week open-label treatment period (including post-treatment OCT imaging), starting within 4 weeks of baseline coronary angiogram. During the open-label treatment period, patients are randomized to receive either alirocumab or standard-of-care (1:1). The last dose of alirocumab will be given at week 34.\n\nPatients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin 10mg/day). Patients in the standard-of-care arm will continue to receive atorvastatin 20 mg/day or rosuvastatin 10 mg/day. Statin dose escalation or adding concomitant non-statin lipid-lowering therapy would be considered by their responsible physician to achieve an LDL-C target \\<100 mg/dL. Antithrombotic therapy and other concomitant medications are exclusively decided by the responsible physicians. Follow-up coronary angiograms and OCT imaging analyses of the same vessels will be carried out at the end of treatment period (at week 36 ± 2 weeks, depending on patient availability) in both study arms. Regular medical examination and laboratory tests will be conducted at weeks 4, 12, 24, and 36. All enrolled patients are monitored and evaluated for safety and any other adverse events during the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(I) 18 - 80 years of age, (II) diagnosed as stable coronary artery disease or acute coronary syndrome during admission (III) undergoing clinically indicated coronary angiography and identified with at least one intermediate lesion (50%-70% diameter stenosis) on de novo coronary arteries, (IV) have an elevated LDL-C values (LDL-C≥100 mg/dL) despite taken rosuvastatin 10 mg/day or atorvastatin 20 mg/day for 2-4 weeks after initiation or with maximally tolerated statin therapy, (V) able to provide written, informed consent.\n\nExclusion Criteria:\n\n1. Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody\n2. received target vessel revascularization\n3. Known hypersensitivity or have contraindications to any anti-PCSK9 monoclonal antibody or statins\n4. Unable to receive OCT imaging tests\n5. Known history of hemorrhagic stroke\n6. Currently under treatment for cancer\n7. Baseline triglyceride \\> 400 mg/dl\n8. Patients with severe liver or renal dysfunction\n9. Pregnant or breast-feeding women\n10. Considered by the investigator as inappropriate for this study for any reason'}, 'identificationModule': {'nctId': 'NCT04851769', 'briefTitle': 'Impact of PCSK9 Inhibitors on Coronary Plaque Composition and Vulnerability Assessed by Optical Coherence Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Impact of PCSK9 Inhibitors on Coronary Plaque Composition and Vulnerability in Patients With Coronary Artery Disease Assessed by Optical Coherence Tomography', 'orgStudyIdInfo': {'id': 'anzhen201803'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'alirocumab plus statin', 'description': 'Patients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin 10mg/day).', 'interventionNames': ['Drug: PCSK9 inhibitor plus statin', 'Procedure: Coronary imaging follow-up']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard statin therapy', 'description': 'Patients in the standard statin arm will continue to receive atorvastatin 20 mg/day or rosuvastatin 10 mg/day. Statin dose escalation or adding concomitant non-statin lipid-lowering therapy could be considered by their responsible physician to achieve an LDL-C target \\<100 mg/dL.', 'interventionNames': ['Drug: standard statin therapy', 'Procedure: Coronary imaging follow-up']}], 'interventions': [{'name': 'PCSK9 inhibitor plus statin', 'type': 'DRUG', 'otherNames': ['alirocumab'], 'description': 'Patients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin 10mg/day).', 'armGroupLabels': ['alirocumab plus statin']}, {'name': 'standard statin therapy', 'type': 'DRUG', 'description': 'Patients will continue to receive atorvastatin 20 mg/day or rosuvastatin 10 mg/day.', 'armGroupLabels': ['standard statin therapy']}, {'name': 'Coronary imaging follow-up', 'type': 'PROCEDURE', 'description': 'coronary angiography and OCT imaging at week 36 ± 2 weeks follow-up', 'armGroupLabels': ['alirocumab plus statin', 'standard statin therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yujie Zhou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Anzhen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president, professor', 'investigatorFullName': 'Yujie Zhou', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}