Acute Myocardial Infarction (AMI)
Conditions
Keywords
Acute Myocardial Infarction, tafolecimab, PCSK9, Coronary Microvascular Dysfunction, Major adverse cardiovascular events, monoclonal antibody against proprotein convertase subtilisin/kexin type 9, LDL-C
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
Interventions
DRUGTafolecimab
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.
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of major adverse cardiovascular events (MACEs) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with coronary microvascular dysfunction (CMD) | Immediately after primary percutaneous coronary intervention | Measurement of coronary angiography-derived microcirculation resistance index (caIMR) |
| Concentration of low density lipoprotein cholesterol (LDL-C) | 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 |
| Rate of malignant arrhythmia | 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. |
Countries
China
Contacts
Primary ContactYuan Lu, M.D. and Ph.D.
Backup ContactYiwen Wang, M.D.
Outcome results
None listed