Retrospective Analysis of the Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients

Recruiting

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: statin ± ezetimibe; Drug: alirocumab 75mg/2week

• Registration Number: NCT06567418
• Lead Sponsor: Yun Dai Chen

Brief Summary

The objective of this study is to investigate the effectiveness of in-hospital initiation of alirocumab combined with statin ± ezetimibe on major cardiovascular events (MACE) in Chinese ACS patients. The main question it aims to answer is:

whether early initiation PCKS9i in hospital could reduce recent cardiovascular event risk in Chinese ACS patients in real-world setting.

Data from CCA Database-Chest Pain Center were screened for all ACS patients from 01-Jan 2021 to 31-Dec 2023. Patients diagnosed with STEMI, NSTEMI or UA at admission were identified at the first step. Then, for intervention group, patients who received alirocumab 75mg combined with statin ± ezetimibe during the ACS hospitalization (including the discharge date) will be included; for control group, patients who received statin ± ezetimibe during the ACS hospitalization will be included. All enrolled patients were required to have at least one documented follow-up visit.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-08-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Patients diagnosed with Acute Coronary Syndrome (ACS) upon hospital admission.
• Patients aged 18 years or older.
• Patients who received Alirocumab 75 mg in combination with statin therapy ± Ezetimibe as the intervention group, and those treated exclusively with statin therapy ± Ezetimibe as the control group, either during hospitalization or at discharge.
• Patients with at least one follow-up record.

Exclusion Criteria

• Patients who received Evolocumab treatment at any time.
• Patients who received Inclisiran treatment at any time.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	statin ± ezetimibe	patients were treated with statin ± ezetimibe only
intervention group	alirocumab 75mg/2week	patients were treated with alirocumab 75mg combined with statin ± ezetimibe

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the risk of MACE within 1 year of follow-up	12 months	MACE was defined as the composite of non-fatal myocardial infarction, non-fatal ischemic stroke, all-cause mortality, or any coronary revascularization. Coronary revascularization was limited to procedures occurring at least two weeks after the index date, including PCI and CABG

Secondary Outcome Measures

Name	Time	Method
Percentage reduction of LDL-C levels at 1-month follow-up from baseline	1 month	Percentage reduction of LDL-C levels at 1-month follow-up from baseline
Proportion of patient who achieved LDL-C goal (<1.4mmol/L) at 1-month follow-up	1 month	Proportion of patient who achieved LDL-C goal (\<1.4mmol/L) at 1-month follow-up

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China