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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,160
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.
Taihe County People's Hospital
Fuyang, Anhui, China
The Fifth People's Hospital of Huai'an City
Huai'an, Jiangsu, China
Lianyungang Municipal Dongfang Hospital
Lianyungang, Jiangsu, China
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical University)
Nanjing, Jiangsu, China
The Fourth Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Suqian Hospital of Jiangsu Provincial People's Hospital
Suqian, Jiangsu, China
The affiliated hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Suining County People's Hospital
Xuzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
...and 3 more locations
Rate of major adverse cardiovascular events (MACEs)
MACEs including cardiovascular death, nonfatal myocardial infarction, unplanned ischemia-driven revascularization, nonfatal stroke, hospitalization for heart failure
Time frame: From enrollment to 1 year after primary percutaneous coronary intervention
Number of participants with coronary microvascular dysfunction (CMD)
Measurement of coronary angiography-derived microcirculation resistance index (caIMR)
Time frame: Immediately after primary percutaneous coronary intervention
Number of participants with coronary microvascular dysfunction (CMD)
Infarct size (IS), intramyocardial hemorrhage (IMH) and microvascular obstruction (MVO) assessed by cardiac magnetic resonance
Time frame: 3-7 days after primary percutaneous coronary intervention
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
Time frame: Both 1 month and 1 year after primary percutaneous coronary intervention
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.
Time frame: 1 month after primary percutaneous coronary intervention
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