Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-01 @ 7:27 PM
Study NCT ID:
NCT05624658
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2022-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With ACS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients who did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each. Group 1 - taking PCSK9 inhibitors while taking Atorvastatin at a dose of 80 mg / day. Group 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / day. Also, on the 2nd visit, patients will undergo CCTA, an assessment of the CAVI index and a laboratory tests (blood count, lipid profile, ALAT, ASAT, Troponin I, Galectin -3, MMP -9, TIMP -1, high-sensitivity CRP, NGAL ). Every 3 months a visit is planned according to the schedule to monitor the effectiveness (blood count, ALAT, ASAT, lipid profile). Follow-up period will be 52 weeks, according to the schedule of visits. At the final visit, patients will undergo CCTA, assess the CAVI index and laboratory tests (blood count, lipid profile, Troponin I, Galectin-3, MMP-9, TIMP-1, high-sensitivity CRP, NGAL).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2022-11-08', 'studyFirstSubmitQcDate': '2022-11-17', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of change plaque vulnerability parameters on CCTA data', 'timeFrame': '52 weeks', 'description': 'change plaque vulnerability parameterson coronary artery computed tomography in non-IRA coronary arteries (positive remodeling; the presence of a low-density area in the plaque (less than 30 HU \\*); point calcifications in the composition of the plaque; ring-shaped enhancement of X-ray density along the periphery of the plaque, not exceeding 130 HU, or the phenomenon of "circular glow")'}], 'secondaryOutcomes': [{'measure': 'The number of participants with death, stent thrombosis/restenosis, nonfatal MI, hospitalization due to unstable angina, revascularization within 1 year', 'timeFrame': '52 weeks', 'description': 'assessment via telemedicine consultation every month and at follow-up visits every 3 months'}, {'measure': 'Total cholesterol, LDL-C, HDL-C, triglycerides levels after 52 weeks', 'timeFrame': '52 weeks', 'description': 'blood sampling at control visits every 3 months'}, {'measure': 'dynamics of level hs-Troponin I within 1 year (ng/l)', 'timeFrame': '52 weeks', 'description': 'blood sampling at the second visit and 12 months later'}, {'measure': 'dynamics of level hs-CRP within 1 year (mg/l)', 'timeFrame': '52 weeks', 'description': 'blood sampling at the second visit and 12 months later'}, {'measure': 'dynamics of level NLR within 1 year', 'timeFrame': '52 weeks', 'description': 'blood sampling at the second visit and 12 months later'}, {'measure': 'dynamics of level Galectin- 3 within 1 year (ng/ml)', 'timeFrame': '52 weeks', 'description': 'blood sampling at the second visit and 12 months later'}, {'measure': 'dynamics of level MMP-9 within 1 year (ng/ml)', 'timeFrame': '52 weeks', 'description': 'blood sampling at the second visit and 12 months later'}, {'measure': 'dynamics of level TIMP - 1 within 1 year (ng/ml)', 'timeFrame': '52 weeks', 'description': 'blood sampling at the second visit and 12 months later'}, {'measure': 'dynamics of level NGAL within 1 year (ng/ml)', 'timeFrame': '52 weeks', 'description': 'blood sampling at the second visit and 12 months later'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute coronary syndrome', 'PCI', 'plaque vulnerability', 'combined lipid-lowering therapy', 'PCSK9 inhibitors', 'Ezetimibe', 'coronary artery computed tomography'], 'conditions': ['Dyslipidemias']}, 'descriptionModule': {'briefSummary': 'The study is prospective, open-label, randomized, single-center study involving patients admitted on an emergency basis with an acute coronary syndrome (ACS) clinic who underwent PCI of an infarct-related artery (IRA) and had intermediate coronary artery lesions (50-70% stenosis diameter) and elevated LDL-C ( \\> 1.4 mmol/l) despite statin therapy at the highest dosage. Patients who showed high compliance and did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each. Group 1 - taking PCSK9 inhibitors (Alirocumab 150 mg by subcutaneous injection once every 2 weeks or Evolocumab 140 mg by subcutaneous injection once every 2 weeks - open-label prescription of drugs) while taking Atorvastatin at a dose of 80 mg / day. Group 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / day.', 'detailedDescription': 'The study will enroll 120 patients with ACS admitted on an emergency basis to the Hospital. All patients will undergo PCI of the infarct-related artery (IRA), as well as intracoronary imaging with OCT of one or two non-IRA. During hospitalization, patients will receive standard therapy of ACS according to clinical recommendations, while Atorvastatin will initially be prescribed at a maximum dosage of 80 mg / day. Patients who showed high compliance and did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each. Group 1 - taking PCSK9 inhibitors (Alirocumab 150 mg by subcutaneous injection once every 2 weeks or Evolocumab 140 mg by subcutaneous injection once every 2 weeks - open-label prescription of drugs) while taking Atorvastatin at a dose of 80 mg / day. Group 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / day.\n\nAlso, on the 2nd visit, patients will undergo coronary artery computed tomography (CCTA): assessment of the CAVI index and a laboratory tests (blood count, lipid profile, ALAT, ASAT, Troponin I, Galectin -3, MMP -9, TIMP -1, high-sensitivity CRP, NGAL ). Every 3 months a visit is planned according to the schedule to monitor the effectiveness (blood count, ALAT, ASAT, lipid profile).\n\nFollow up duration will be 52 weeks, according to the schedule of visits. At the final visit, patients will undergo CCTA, CAVI index and laboratory tests (blood count, lipid profile, ALAT, ASAT, Troponin I, Galectin -3, MMP -9, TIMP -1, high-sensitivity CRP, NGAL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gender (any);\n* age 18-75 years;\n* admission \\< 24 hours after pain onset\n* acute coronary syndrome with at least one coronary artery stenosis requiring PCI;\n* one or two non-IRA (coronary artery lumen diameter according to CAG \\>20% and \\<50% and no need for revascularization within the next 6 months according to the investigator)\n* not taking statins for at least 3 (6) months or not achieving the target level of LDL-C at admission\n* failure to achieve the target level of LDL-C ≥1.4 mmol/l on the second visit;\n* signed informed consent\n\nExclusion Criteria:\n\n* previous MI\n* history of revascularization (PCI/CABG)\n* presence of non-IRA stenoses ≥50%.\n* multivessel lesion, including significant stenosis of the LM\n* EF \\< 40%,\n* Killip III-IV.\n* NYHA III-IV\n* significant calcification or tortuosity of the coronary arteries, limiting OCT\n* intolerance to statins, aspirin, P2Y12 inhibitors\n* patients who have previously received PCSK9 inhibitors and/or Ezetimib\n* treatment with systemic steroids or systemic cyclosporine within the last 3 months\n* collagenoses and inflammatory diseases,\n* oncological diseases within the last 5 years,\n* scheduled surgery within 3 months\n* persons suffering from mental disorders\n* pregnancy, breastfeeding period'}, 'identificationModule': {'nctId': 'NCT05624658', 'acronym': 'Combi-LLT ACS', 'briefTitle': 'Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With ACS', 'organization': {'class': 'OTHER', 'fullName': 'Samara Regional Cardiology Dispensary'}, 'officialTitle': 'Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With Acute Coronary Syndrome, a Prospective, Open-label, Randomized, Single-center Study', 'orgStudyIdInfo': {'id': 'SamaraRCD-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PCSK9 inhibitors in combination Atorvastatin at a dose of 80 mg /Rosuvastatin 40 mg/ day', 'description': 'Patients who showed high compliance and did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each. Group 1 - taking PCSK9 inhibitors (Alirocumab 150 mg by subcutaneous injection once every 2 weeks or Evolocumab 140 mg by subcutaneous injection once every 2 weeks - open-label prescription of drugs) while taking Atorvastatin at a dose of 80 mg./ Rosuvastatin 40 mg / day.', 'interventionNames': ['Combination Product: Combined Lipid-lowering Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / Rosuvastatin 40 mg/ day.', 'description': 'Group 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / Rosuvastatin 40 mg/day.', 'interventionNames': ['Combination Product: Combined Lipid-lowering Therapy']}], 'interventions': [{'name': 'Combined Lipid-lowering Therapy', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['invasive coronary angiography, coronary artery commputed tomography, OCT, CAVI index'], 'description': 'the effect of high-dose combined lipid-lowering therapy (statins+ezetimibe vs statins+PCSK9 inhibitors) on the vulnerability characteristics of atherosclerotic plaques assessed using multimodal imaging (coronary artery computed tomography and optical coherence tomography), as well as biomarkers in patients with acute coronary syndrome for 52 weeks.', 'armGroupLabels': ['Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / Rosuvastatin 40 mg/ day.', 'PCSK9 inhibitors in combination Atorvastatin at a dose of 80 mg /Rosuvastatin 40 mg/ day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443070', 'city': 'Samara', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Dmitry Duplyakov', 'role': 'CONTACT'}, {'name': 'Anna Kovalskaya', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Guzel Bikbaeva', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Samara Regional Cardiology Dispansery', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}], 'centralContacts': [{'name': 'Dmitry Duplyakov, professor', 'role': 'CONTACT', 'email': 'duplyakov@yahoo.com', 'phone': '+79277297273'}, {'name': 'Anna Kovalskaya', 'role': 'CONTACT', 'email': 'kovalskaya.an@gmail.com', 'phone': '+79270130848'}], 'overallOfficials': [{'name': 'Dmitry Duplyakov', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samara State Medical Universiry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samara Regional Cardiology Dispensary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Samara State Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Prof. Dmitry Duplyakov FESC', 'investigatorAffiliation': 'Samara Regional Cardiology Dispensary'}}}}