NCT06683131

Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary Intervention on Acute Myocardial Infarction Patients

IMpact of PCSK9 inhibitoR initiatiOn Before Percutaneous Coronary Intervention on Coronary microVascular Dysfunction and Events for Acute Myocardial Infarction: a Multi-center, Open-label, Randomized, Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,160 (estimated)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if drug tafolecimab works to treat participants with acute myocardial infarction (AMI) scheduled for primary percutaneous coronary intervention (PCI). It will also learn about the safety of drug tafolecimab. The main questions it aims to answer are: * Does drug tafolecimab lower the risk of 1-year major adverse cardiovascular events? * Does drug tafolecimab improve the coronary microvascular dysfunction? * What medical problems do participants have when administering drug tafolecimab by injection? Researchers will compare the results administering drug tafolecimab or not to see if drug tafolecimab works to treat AMI. Participants will: * Administer drug tafolecimab by injection or not every month for 12 months * Receive the standard of care of AMI * Complete the measurement of coronary angiography-derived microcirculation resistance index after PCI * Complete cardiac magnetic resonance after PCI if available * Visit the clinic at 1,6,12 months after the first administration for checkups and tests * Report any discomfort, event or queries at any time

Conditions

• Acute Myocardial Infarction (AMI)

Interventions

Type	Name	Description
DRUG	Tafolecimab	450mg of tafolecimab (150mg each one) was injected subcutaneously before primary PCI and then 150mg subcutaneously injected every half a month till totally 12 months.

Timeline

• Start date: 2025-11-20
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2024-11-12
• Last updated: 2025-11-21

Locations

13 sites across 1 country: China