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

NCT ID: NCT06730802

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Myocardial Ischaemic Syndrome; Coronary Heart Disease

Keywords

inflammation; CABG

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PCSK9 inhibitor

the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later

Group Type: EXPERIMENTAL

PCSK9 inhibitor

Intervention Type: DRUG

the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later.

Statin

the control group will receive standard statin therapy.

Group Type: SHAM_COMPARATOR

Statin

Intervention Type: DRUG

the control group will receive standard statin therapy.

Interventions

PCSK9 inhibitor

the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later.

Intervention Type: DRUG

Statin

the control group will receive standard statin therapy.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: collaborator

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hong Liu

Principal Investigator of Department of Cardiovascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lu-yao Ma, MD

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Hong Liu, MD

Role: CONTACT

Phone: 18801281613

Email: dr.hongliu@foxmail.com

Lu-yao Ma, MD

Role: CONTACT

Phone: 02568303101

Email: maluyao@jsph.org.cn

Facility Contacts

Hai-yang Li, MD

Role: primary

Hai-yang Li

Role: backup

Si-chong Qian, MD

Role: backup

Lu-yao Ma, MD

Role: primary

Lu-yao Ma, MD

Role: backup

Hong Liu

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 33197560 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35606883 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38337601 (View on PubMed)

Other Identifiers

PANDA VIII

Identifier Type: -

Identifier Source: org_study_id