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NCT Number: NCT06683131

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

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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Key information

Conditions

Acute Myocardial Infarction (AMI)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taihe County People's Hospital, Fuyang, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tafolecimab

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.

Primary outcomes

  1. Rate of major adverse cardiovascular events (MACEs)

    Time frame: From enrollment to 1 year after primary percutaneous coronary intervention

    MACEs including cardiovascular death, nonfatal myocardial infarction, unplanned ischemia-driven revascularization, nonfatal stroke, hospitalization for heart failure

Secondary outcomes

  1. Number of participants with coronary microvascular dysfunction (CMD)

    Time frame: Immediately after primary percutaneous coronary intervention

    Measurement of coronary angiography-derived microcirculation resistance index (caIMR)

  2. Number of participants with coronary microvascular dysfunction (CMD)

    Time frame: 3-7 days after primary percutaneous coronary intervention

    Infarct size (IS), intramyocardial hemorrhage (IMH) and microvascular obstruction (MVO) assessed by cardiac magnetic resonance

  3. Concentration of low density lipoprotein cholesterol (LDL-C)

    Time frame: Both 1 month and 1 year after primary percutaneous coronary intervention

    The measurement of LDL-C level and number of participants reaching the target according to current guidelines

  4. Rate of malignant arrhythmia

    Time frame: 1 month after primary percutaneous coronary intervention

    These include sudden cardiac death (SCD), sudden death survival (aborted SCD), appropriate implantable cardioverter defibrillator (ICD) interventions, and persistent ventricular arrhythmias monitored by a 72-hour holter electrocardiogram.

Study contacts

Contact information is provided by the study sponsor or research team.

Yiwen Wang, M.D.

CONTACT

[email protected]

+8615094343962

Yuan Lu, M.D. and Ph.D.

CONTACT

[email protected]

+8613952110901

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University

Other

Registry information

Official study title

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

Acronym: IMPROVE-AMI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 12, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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