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

NCT06683131 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: XYFY2024-KL537-01
• Study Type: interventional
• Target: 1,160
• Locations: 1 country
• Sites: 13

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

Conditions

Acute Myocardial Infarction (AMI)

Keywords

Acute Myocardial Infarction; tafolecimab; PCSK9; Coronary Microvascular Dysfunction; Major adverse cardiovascular events; monoclonal antibody against proprotein convertase subtilisin/kexin type 9; LDL-C

Outcome Measures

Primary Outcomes (1)

• Rate of major adverse cardiovascular events (MACEs)

  MACEs including cardiovascular death, nonfatal myocardial infarction, unplanned ischemia-driven revascularization, nonfatal stroke, hospitalization for heart failure

  From enrollment to 1 year after primary percutaneous coronary intervention

Secondary Outcomes (4)

• Number of participants with coronary microvascular dysfunction (CMD)

  Immediately after primary percutaneous coronary intervention

• Number of participants with coronary microvascular dysfunction (CMD)

  3-7 days after primary percutaneous coronary intervention

• Concentration of low density lipoprotein cholesterol (LDL-C)

  Both 1 month and 1 year after primary percutaneous coronary intervention

• Rate of malignant arrhythmia

  1 month after primary percutaneous coronary intervention

Study Arms (2)

PCSK9 inhibitor (PCSK9i) group

EXPERIMENTAL

Participants receive PCSK9i tafolecimab and standard of care (SoC) of acute myocardial infarction

Drug: Tafolecimab

Control group

NO INTERVENTION

Participants receive SoC of acute myocardial infarction

Interventions

Tafolecimab DRUG

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.

PCSK9 inhibitor (PCSK9i) group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (13)

Taihe County People's Hospital

Fuyang, Anhui, China

Location

The Fifth People's Hospital of Huai'an City

Huai'an, Jiangsu, China

Location

Lianyungang Municipal Dongfang Hospital

Lianyungang, Jiangsu, China

Location

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Nanjing, Jiangsu, China

Location

Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical University)

Nanjing, Jiangsu, China

Location

The Fourth Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Suqian Hospital of Jiangsu Provincial People's Hospital

Suqian, Jiangsu, China

Location

The affiliated hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

Location

Suining County People's Hospital

Xuzhou, Jiangsu, China

Location

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Location

Xuzhou Mining Group General Hospital

Xuzhou, Jiangsu, China

Location

Peking University First Hospital

Beijing, 100000, China

Location

Shanghai Tenth People's Hospital

Shanghai, China

Location

Study Officials

• Yong Huo, M.D. and Ph.D.

  Peking University First Hospital

  STUDY CHAIR

• Yuan Lu, M.D. and Ph.D.

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Lu, M.D. and Ph.D.

CONTACT

+8613952110901; drluyuan329@163.com

Yiwen Wang, M.D.

CONTACT

+8615094343962; wangyiwen@xzhmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: November 20, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: November 21, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)