drugset / Trial / NCT06730802
Protective Effect of PCSK9 Inhibitor Against Negative Inflammatory Response and Organ Dysfunction After Coronary Artery Bypass Grafting (PANDA VIII)
Not yet recruiting
400 enrolled
Nanjing Medical University
Beijing Anzhen Hospital · collabThe First Affiliated Hospital with Nanjing Medical University · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
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.
Timeline
- Start
- 2025-01-01
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Publications
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Evolocumab | Monoclonal antibody | — | — |