NCT06854523

Assessing Coronary Non-Culprit Plaque Early with Start of PCSK9 Inhibitors in Acute Myocardial Infarction (ACCESS-AMI)

Assessing Coronary Non-Culprit Plaque Early with Start of PCSK9 Inhibitors in Acute Myocardial Infarction

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Yun Dai Chen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is planned to start on January 2024. The goal of this clinical trial is to learn whether the perioperative administration (within 24 hours before or after primary PCI) of PCSK9 inhibitors can ameliorate plaque progression and adverse outcomes in patients with acute myocardial infarction (AMI). The main questions it aims to answer are: Can perioperative PCSK9 inhibition improve the plaque stability and inflammation of perivascular adipose tissue (index of plaque attenuation（IPA ）and perivascular fat attenuation index（FAI）) of non-target lesions? Researchers will compare PCSK9 inhibitors with statin plus ezetimibe therapy to evaluate the potential of PCSK9 inhibitors in mitigating the progression of non-target lesion plaques and reducing adverse cardiovascular events in patients with AMI. Participants will: Take PCSK9 inhibitors every two weeks or daily statin plus ezetimibe therapy. Conduct a follow-up examination with optical coherence tomography (OCT) or coronary computed tomography angiography (CTA) after 12 months. Record the occurrence of major adverse cardiovascular events.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
DRUG	PCSK9 inhibitor	The patient used Trastuzumab 150mg within 24 hours before or after PCI, and then every two weeks for 12 months
DRUG	Statin+ezetimibe	The patient used statins and ezetimibe within 24 hours before or after PCI, and then once a day for 12 months
BEHAVIORAL	Blood lipid levels meet the recommended guidelines	Early use of intensified lipid-lowering therapy during hospitalization led to a rapid decrease in blood lipids and met the recommended guidelines.
BEHAVIORAL	Blood lipid levels don't meet the recommended guidelines	The patient did not receive intensified lipid-lowering treatment during hospitalization or did not meet the recommended guidelines for blood lipids

Timeline

• Start date: 2025-04-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-03-03
• Last updated: 2025-03-03

Locations

2 sites across 1 country: China