MedTrace Logo

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

NCT06683131 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1160

Last updated 2025-11-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The Affiliated Hospital of Xuzhou Medical University

    lead OTHER

Principal Investigators

  • Yong Huo, M.D. and Ph.D. · Peking University First Hospital

  • Yuan Lu, M.D. and Ph.D. · The Affiliated Hospital of Xuzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-20
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06683131 on ClinicalTrials.gov