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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2027-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Acute Myocardial Infarction (AMI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PCSK9 inhibitor (PCSK9i) group

Participants receive PCSK9i tafolecimab and standard of care (SoC) of acute myocardial infarction

Group Type EXPERIMENTAL

Tafolecimab

Intervention Type DRUG

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.

Control group

Participants receive SoC of acute myocardial infarction

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults 18-75 years old
* AMI diagnosed according to the latest guidelines, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI)

* The requirement for STEMI was that primary PCI was scheduled within 12 hours of onset.
* The requirement for NSTEMI was that coronary angiography was scheduled within 2 hours for very high-risk participants and within 24 hours for high-risk participants .
* Regardless of baseline LDL-C levels
* Participants voluntarily took part in this study and signed informed consent

Exclusion Criteria

* Previous or ongoing treatment for any PCSK9i
* Allergy to PCSK9i, statins, or any of the drug ingredients used during the trial
* History of hemorrhagic cerebrovascular disease
* History of old myocardial infarction/chronic heart failure
* History of PCI or coronary artery bypass grafting (CABG) or preparation for CABG
* Above Killip level II
* Prolonged cardiopulmonary resuscitation (\>20min)
* Definite mechanical complications (including perforation of the interventricular septum, or rupture of the papillary tendon bundle or the left ventricular free wall)
* malignant arrhythmia
* Severe uncontrolled infection, bleeding disorder, end-stage renal disease, severe liver disease, endocrine dysfunction, or the expected less than 1 year survival of malignant tumors
* Pregnant or lactating women
* Participate in other clinical trials

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No