Protective Effect of PCSK9 Inhibitor Against Negative Inflammatory Response and Organ Dysfunction After Coronary Artery Bypass Grafting (PANDA VIII)

NCT06730802 — Not applicable, Not yet recruiting, 400 participants, Nanjing Medical University

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Registry	NCT06730802, acronym PANDA
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	400 (Estimated)
Sponsor	Nanjing Medical University (Other); collaborators: The First Affiliated Hospital with Nanjing Medical University, Beijing Anzhen Hospital
Conditions	Myocardial Ischaemic Syndrome, Coronary Heart Disease
Interventions	PCSK9 inhibitor, Statin (Drug)
Dates	start 2025-01-01 (estimated), primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2024-12-12, last updated 2024-12-12
Locations	2 sites in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
PCSK9 inhibitor	Experimental	Drug: PCSK9 inhibitor	the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later
Statin	Sham comparator	Drug: Statin	the control group will receive standard statin therapy.

PCSK9 inhibitor (Drug): the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later.
Statin (Drug): the control group will receive standard statin therapy.

+Outcome measures

Primary outcomes

Major Adverse Cardiovascular and Cerebrovascular Events [6 months after surgery]: Major Adverse Cardiovascular and Cerebrovascular Events include cardiac death, reinfarction, emergency coronary revascularization and stroke

Secondary outcomes

C-reactive protein [6 months after surgery]: Peripheral blood C-reactive protein

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Male or female ≥ 18 years of age
* Patients with myocardial ischemic syndromes (with any of the following):
* Patients are ready to undergo coronary artery bypass grafting (CABG) with 1 month;
* Participate voluntarily and sign an informed consent

Exclusion Criteria:

i. 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

+Locations (2)

Facility	City	Country	Status
Beijing Anzhen Hospital, Capital Medical University	Beijing, Beijing Municipality	China
The First Affiliated Hospital of Nanjing Medical University	Nanjing, Jiangsu	China

+Publications

Results publication: 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 33197560
Results publication: 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 35606883
Results publication: 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. PMID 38337601

+Investigators

Lu-yao Ma, MD, Study director, The First Affiliated Hospital with Nanjing Medical University