Menu
Not yet recruiting NCT06683131

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

Phase IV Interventional Acute Myocardial Infarction (AMI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tafolecimab.
Who it may be relevant to
Registry conditions: Acute Myocardial Infarction (AMI). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

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.

Primary outcome measures

  • Rate of major adverse cardiovascular events (MACEs) [Time frame: From enrollment to 1 year after primary percutaneous coronary intervention]
Secondary outcome measures (4)
  • Number of participants with coronary microvascular dysfunction (CMD) [Time frame: Immediately after primary percutaneous coronary intervention]
  • Number of participants with coronary microvascular dysfunction (CMD) [Time frame: 3-7 days after primary percutaneous coronary intervention]
  • Concentration of low density lipoprotein cholesterol (LDL-C) [Time frame: Both 1 month and 1 year after primary percutaneous coronary intervention]
  • Rate of malignant arrhythmia [Time frame: 1 month after primary percutaneous coronary intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 13 centers
  • Taihe County People's Hospital — Fuyang
  • The Fifth People's Hospital of Huai'an City — Huai'an
  • Lianyungang Municipal Dongfang Hospital — Lianyungang
  • Jiangsu Provincial Hospital of Traditional Chinese Medicine — Nanjing
  • Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical Uni — Nanjing
  • The Fourth Affiliated Hospital of Nanjing Medical University — Nanjing
  • Suqian Hospital of Jiangsu Provincial People's Hospital — Suqian
  • The affiliated hospital of Xuzhou Medical University — Xuzhou
  • … and 5 more centers

Identifiers

NCT: NCT06683131 · XYFY2024-KL537-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗