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
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 .
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
Parallel
Tafolecimab
Drug450mg of tafolecimab (150mg each one) was injected subcutaneously before primary PCI and then 150mg subcutaneously injected every half a month till totally 12 months.
Rate of major adverse cardiovascular events (MACEs)
MACEs including cardiovascular death, nonfatal myocardial infarction, unplanned ischemia-driven revascularization, nonfatal stroke, hospitalization for heart failure
Number of participants with coronary microvascular dysfunction (CMD)
Measurement of coronary angiography-derived microcirculation resistance index (caIMR)
Number of participants with coronary microvascular dysfunction (CMD)
Infarct size (IS), intramyocardial hemorrhage (IMH) and microvascular obstruction (MVO) assessed by cardiac magnetic resonance
Concentration of low density lipoprotein cholesterol (LDL-C)
The measurement of LDL-C level and number of participants reaching the target according to current guidelines
Rate of malignant arrhythmia
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.
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This trial is not recruiting at the moment. You can still explore other options:
