Clinical trial NCT06683131: Effectiveness of Proprotein Convertase Subtilisin/kexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary Intervention on Acute Myocardial Infarction Patients
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Acute Myocardial Infarction (AMI)
Keywords: Acute Myocardial Infarction
tafolecimab
PCSK9
Coronary Microvascular Dysfunction
Major adverse cardiovascular events
monoclonal antibody against proprotein convertase subtilisin/kexin type 9
LDL-C
Lead sponsor: The Affiliated Hospital of Xuzhou Medical University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 1160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


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

Primary outcomes:
measure: Rate of major adverse cardiovascular events (MACEs)
timeFrame: From enrollment to 1 year after primary percutaneous coronary intervention
Secondary outcomes:
measure: Number of participants with coronary microvascular dysfunction (CMD)
timeFrame: Immediately after primary percutaneous coronary intervention
measure: Number of participants with coronary microvascular dysfunction (CMD)
timeFrame: 3-7 days after primary percutaneous coronary intervention
measure: Concentration of low density lipoprotein cholesterol (LDL-C)
timeFrame: Both 1 month and 1 year after primary percutaneous coronary intervention
measure: Rate of malignant arrhythmia
timeFrame: 1 month after primary percutaneous coronary intervention
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: The affiliated hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
affiliation: Peking University First Hospital
name: Yong Huo, M.D. and Ph.D.
role: STUDY_CHAIR
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Yuan Lu, M.D. and Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: