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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female ≥ 18 years of age

Patients are ready to undergo coronary artery bypass grafting (CABG) with 1 month;

Participate voluntarily and sign an informed consent

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: PCSK9 inhibitorExperimental treatment 1 intervention
Group B: StatinSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major Adverse Cardiovascular and Cerebrovascular Events

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

Time frame
6 months after surgery

Secondary outcomes

1

C-reactive protein

Peripheral blood C-reactive protein

Time frame
6 months after surgery

Other outcomes

Sponsors and contacts

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Nanjing Medical University

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborator

Beijing Anzhen Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: