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Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary Intervention on Acute Myocardial Infarction Patients
Sponsor: The Affiliated Hospital of Xuzhou Medical University
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
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1160
Start Date
2025-11-20
Completion Date
2027-11-30
Last Updated
2025-11-21
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (13)
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
Xuzhou Mining Group General Hospital
Xuzhou, Jiangsu, China
Peking University First Hospital
Beijing, China
Shanghai Tenth People's Hospital
Shanghai, China