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Clinical Trials in China / NCT06683131
Starting soon Phase 4

Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary Intervention on Acute Myocardial Infarction Patients

NCT06683131 · tracked via the Priya Life Science China tracker
Sponsor
The Affiliated Hospital of Xuzhou Medical University
Phase
Phase 4
Started
2025-11-20
Last updated
2025-11-21

Condition(s) studied

Acute Myocardial Infarction (AMI)

Investigational drug(s) / intervention(s)

Tafolecimab →

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

  • 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

Trial sites (13)

FacilityCityRegionStatus
Taihe County People's Hospital Fuyang Anhui
The Fifth People's Hospital of Huai'an City Huai'an Jiangsu
Lianyungang Municipal Dongfang Hospital Lianyungang Jiangsu
Jiangsu Provincial Hospital of Traditional Chinese Medicine Nanjing Jiangsu
Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical University) Nanjing Jiangsu
The Fourth Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
Suqian Hospital of Jiangsu Provincial People's Hospital Suqian Jiangsu
The affiliated hospital of Xuzhou Medical University Xuzhou Jiangsu
Suining County People's Hospital Xuzhou Jiangsu
Xuzhou Central Hospital Xuzhou Jiangsu
Xuzhou Mining Group General Hospital Xuzhou Jiangsu
Peking University First Hospital Beijing China
Shanghai Tenth People's Hospital Shanghai China

More The Affiliated Hospital of Xuzhou Medical University trials in China

Study Of B7H3 CAR-T Cells in Treating Advanced Liver Cancer Recruiting
BGT007H Cells for the Treatment of Refractory Digestive System Tumors Recruiting
Anti CD19 CAR-T Combined With BTKi to Treat Newly Diagnosed High-risk CLL/SLL Recruiting
To Evaluate the Effect and Safety of Telitacicept and Standard Treatment for 6months in IgA Nephropathy Active, not recruiting
High-Frequency QRS for Predicting Microvascular Dysfunction and Adverse Events After PCI in Acute Myocardial Infarction Starting soon

Other trials for the same condition

Prospective Lifespan Cohort of Myocardial Infarction Starting soon
Very Early PCSK9 Inhibition for Acute Myocardial Infarction Recruiting
Coronary and Myocardial Evaluation by Cardiac CT for Acute Myocardial Infarction Recruiting
IABP for MI-VSD Patients in SCAI SHOCK Stage B Starting soon
Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06683131 on ClinicalTrials.gov ↗ ← All trials in China