Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-02 @ 12:32 AM
Study NCT ID:
NCT07129850
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bempedoic Acid in PPCI Impact on Clinical Outcome and Inflammatory Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-11-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-08-18', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in inflammatory markers', 'timeFrame': 'At 1 month post-PCI.', 'description': 'reactive protein \\[CRP\\] and tumor necrosis factor-alpha \\[TNF-α\\]) at 1 month post-primary PCI compared between the intervention group (Bempedoic Acid) and the control group.'}], 'secondaryOutcomes': [{'measure': 'Final TIMI flow grade post-PCI.', 'timeFrame': '1 day', 'description': 'Assessment of final TIMI flow grade, incidence of no-reflow phenomenon, and occurrence of contrast-induced nephropathy (CIN) after primary PCI.'}, {'measure': 'Major Adverse Cardiac Events', 'timeFrame': 'Within 30 days post-PCI.', 'description': 'Incidence of a composite endpoint including heart failure, reinfarction, rehospitalization for cardiac causes, arrhythmia, stroke, and cardiovascular mortality.'}, {'measure': 'Lipid Profile Changes', 'timeFrame': 'At 1 month post-PCI.', 'description': 'Measurement of total cholesterol, LDL-C, HDL-C, and triglycerides to assess lipid-lowering effect of Bempedoic Acid.'}]}, 'conditionsModule': {'keywords': ['Bempedoic acid', 'TNF alpha', 'PPCI'], 'conditions': ['ST Elevation (STEMI) Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '30922146', 'type': 'RESULT', 'citation': 'Laufs U, Banach M, Mancini GBJ, Gaudet D, Bloedon LT, Sterling LR, Kelly S, Stroes ESG. Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance. J Am Heart Assoc. 2019 Apr 2;8(7):e011662. doi: 10.1161/JAHA.118.011662.'}, {'pmid': '28845751', 'type': 'RESULT', 'citation': 'Ridker PM, Everett BM, Thuren T, MacFadyen JG, Chang WH, Ballantyne C, Fonseca F, Nicolau J, Koenig W, Anker SD, Kastelein JJP, Cornel JH, Pais P, Pella D, Genest J, Cifkova R, Lorenzatti A, Forster T, Kobalava Z, Vida-Simiti L, Flather M, Shimokawa H, Ogawa H, Dellborg M, Rossi PRF, Troquay RPT, Libby P, Glynn RJ; CANTOS Trial Group. Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease. N Engl J Med. 2017 Sep 21;377(12):1119-1131. doi: 10.1056/NEJMoa1707914. Epub 2017 Aug 27.'}, {'pmid': '36386319', 'type': 'RESULT', 'citation': 'Biolo G, Vinci P, Mangogna A, Landolfo M, Schincariol P, Fiotti N, Mearelli F, Di Girolamo FG. Mechanism of action and therapeutic use of bempedoic acid in atherosclerosis and metabolic syndrome. Front Cardiovasc Med. 2022 Oct 28;9:1028355. doi: 10.3389/fcvm.2022.1028355. eCollection 2022.'}, {'pmid': '26247090', 'type': 'RESULT', 'citation': 'Feingold KR. Guidelines for the Management of High Blood Cholesterol. 2025 Mar 27. In: Feingold KR, Ahmed SF, Anawalt B, Blackman MR, Boyce A, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hofland J, Kalra S, Kaltsas G, Kapoor N, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, Shah AS, Singer F, Sperling MA, Stratakis CA, Trence DL, Wilson DP, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from http://www.ncbi.nlm.nih.gov/books/NBK305897/'}, {'pmid': '31488387', 'type': 'RESULT', 'citation': 'WHO CVD Risk Chart Working Group. World Health Organization cardiovascular disease risk charts: revised models to estimate risk in 21 global regions. Lancet Glob Health. 2019 Oct;7(10):e1332-e1345. doi: 10.1016/S2214-109X(19)30318-3. Epub 2019 Sep 2.'}]}, 'descriptionModule': {'briefSummary': 'Bempedoic acid in PPCI', 'detailedDescription': 'Cardiovascular disease persists as the predominant cause of global burden of mortality and morbidity worldwide(1).\n\nThe cholesterol hypothesis posits that elevated blood cholesterol levels constitute a significant risk factor for atherosclerotic cardiovascular disease (ASCVD) and reducing cholesterol levels will consequently lower the risk of ASCVD(2).\n\nTreatments aimed at lowering lipid levels have demonstrated their effectiveness in decelerating the advancement of atherosclerotic disease(3). This finding further reinforces the pathophysiological connections between plasma lipids and the progression of CAD. Among non-lipid mechanisms involved in reducing CAD progression, lipid-lowering drugs have also been implicated in plaque stabilization, reduced inflammation, reversal of endothelial dysfunction, and decreased thrombogenicity(3).\n\nIt is widely accepted that the beneficial effects of statins on cardiovascular events are mainly linked to their cholesterol lowering properties. Nonetheless, statins also have a clear action in reducing systemic inflammation. The effect on hsCRP is proportionally similar to that on LDL-C(4).\n\nIt is known that an anti-inflammatory action contributes to the reduction of cardiovascular risk independently of the effect on LDL-C. Four-year therapy with canakinumab, a specific anti-interleukin-1b monoclonal antibody, in patients with previous myocardial infarction reduced the relative risk of relapse by approximately 15% by reducing hsCRP levels by 60% without modifying LDL-C(5). It is therefore possible to hypothesize that cholesterol lowering drugs with an effect on hsCRP, such as statins and bempedoic acid, have advantages in reducing cardiovascular events compared to those that do not act on inflammation, such as PCSK9 inhibitors(4).\n\nBempedoic acid is a new cholesterol-lowering drug, which has recently received US FDA approval. It offers a safe and effective oral therapeutic option for lipid lowering in patients who cannot tolerate statins or in addition to statins in patients who are not reaching the LDL target(6). Bempedoic acid targets lipid and glucose metabolism as well as inflammation. The primary effect is the reduction of cholesterol synthesis in the liver and its administration is generally not associated to unwanted muscle effects(4).\n\nBempedoic acid may decrease gluconeogenesis leading to improved insulin sensitivity, glucose metabolism, and metabolic syndrome(4).\n\nThe anti-inflammatory action of bempedoic acid is mainly achieved via activation of AMPK pathway in the immune cells, leading to decreased plasma levels of C-reactive protein(4).\n\nHowever, its potential role in modulating post-PCI inflammatory response has not been fully investigated, especially in primary PCI setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study Population The study will include patients presenting with ST-elevation myocardial infarction (STEMI) who are eligible for and undergoing primary percutaneous coronary intervention (PCI) at Assiut University Heart Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge ≥18 years STEMI diagnosis Undergoing primary PCI\n\nExclusion Criteria:\n\nKnown allergy to Bempedoic acid Active infection or chronic inflammatory disease Severe hepatic or renal dysfunction Use of immunosuppressive therapy'}, 'identificationModule': {'nctId': 'NCT07129850', 'briefTitle': 'Bempedoic Acid in PPCI Impact on Clinical Outcome and Inflammatory Markers', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Bempedoic Acid in Primary Percutaneous Coronary Intervention: Impact on Inflammatory Markers, Procedural and Clinical Outcomes', 'orgStudyIdInfo': {'id': 'Bempedoic acid in PPCI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Two groups will be measured'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Mostafa Sayed Ahmed', 'role': 'CONTACT', 'email': 'Ahmed.17289732@med.eud.eg', 'phone': '+2001116787960'}, {'name': 'Marwan Sayed, Lecturer', 'role': 'CONTACT', 'email': 'marwancordio@aun.edu.eg', 'phone': '+201090686492'}], 'overallOfficials': [{'name': 'Amr Youssef, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmed Mostafa Sayed Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}