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

Phase 4

Not yet recruiting

• Conditions: Acute Myocardial Infarction (AMI)
• Interventions: Drug: Tafolecimab

• Registration Number: NCT06683131
• Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-08
• Study First Submitted QC: 2024-11-08
• Last Update Submitted: 2024-11-09
• Study First Posted: 2024-11-11
• Last Update Posted: 2024-11-12
• Study Start: 2024-12-01
• Primary Completion: 2027-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCSK9 inhibitor (PCSK9i) group	Tafolecimab	Participants receive PCSK9i tafolecimab and standard of care (SoC) of acute myocardial infarction

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Number of participants with coronary microvascular dysfunction (CMD)	3-7 days after primary percutaneous coronary intervention	Infarct size (IS), intramyocardial hemorrhage (IMH) and microvascular obstruction (MVO) assessed by cardiac magnetic resonance
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.

Trial Locations

Locations (1)

The affiliated hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China