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

Xuzhou Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Acute Myocardial Infarction (AMI)

Treatments: Drug: Tafolecimab

Study type: Interventional

Funder types: Other

Identifiers

NCT06683131

XYFY2024-KL537-01

Details and patient eligibility

About

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

Enrollment: 1,160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,160 participants in 2 patient groups

PCSK9 inhibitor (PCSK9i) group

Experimental group

Description:

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

Treatment:

Drug: Tafolecimab

Control group

No Intervention group

Description:

Participants receive SoC of acute myocardial infarction