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

NCT06730802 | Not Yet Recruiting DMC

• 1 other identifier: PANDA VIII
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular and Cerebrovascular Events

  Major Adverse Cardiovascular and Cerebrovascular Events include cardiac death, reinfarction, emergency coronary revascularization and stroke

  6 months after surgery

Secondary Outcomes (1)

• C-reactive protein

  6 months after surgery

Study Arms (2)

PCSK9 inhibitor

EXPERIMENTAL

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

Drug: PCSK9 inhibitor

Statin

SHAM COMPARATOR

the control group will receive standard statin therapy.

Drug: Statin

Interventions

PCSK9 inhibitor DRUG

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

PCSK9 inhibitor

Statin DRUG

the control group will receive standard statin therapy.

Statin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Medical University: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Beijing Anzhen Hospital: collaborator

Study Sites (2)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Inflammation

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Lu-yao Ma, MD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Hong Liu, MD

CONTACT

18801281613; dr.hongliu@foxmail.com

Lu-yao Ma, MD

CONTACT

02568303101; maluyao@jsph.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Department of Cardiovascular Surgery

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (2)