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

Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients: A Database-based Retrospective Analysis

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: alirocumab 75mg/2week; Drug: statin ± ezetimibe

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Dandan Li, Dr.; Phone Number: +86 13810545564; Email: lidandan5564@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Dandan Li, MD; Phone Number: 86 13810545564; Email: lidandan5564@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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. Patients prescribed with evolocumab at any time will be excluded.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
intervention group; patients were treated with alirocumab 75mg combined with statin ± ezetimibe	Drug: alirocumab 75mg/2week; patients continually prescribed or stopped alirocumab treatment during the follow-up visit, which depend on physician's clinical decision and patient preference
control group; patients were treated with statin ± ezetimibe only	Drug: statin ± ezetimibe; patients will be censored at initiation of alirocumab during the follow up visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint is the risk of MACE within 1 year of follow-up	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage reduction of LDL-C levels at 1-month follow-up from baseline	Percentage reduction of LDL-C levels at 1-month follow-up from baseline	1 month
Proportion of patient who achieved LDL-C goal (<1.4mmol/L) at 1-month follow-up	Proportion of patient who achieved LDL-C goal (<1.4mmol/L) at 1-month follow-up	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between ACS pathway optimization participation and MACE within 1 year follow-up	Association between ACS pathway optimization participation and MACE within 1 year follow-up	12 months
Association between ACS pathway optimization participation and LDL-C goal attainment rate at 1-month follow-up	Association between ACS pathway optimization participation and LDL-C goal attainment rate at 1-month follow-up	1 month
Percentage reduction of LDL-C levels at 3-month, 6-month follow-up from baseline (if have enough follow-up data on lab test)	Percentage reduction of LDL-C levels at 3-month, 6-month follow-up from baseline (if have enough follow-up data on lab test)	3 months, 6 months
LDL-C goal attainment rate (<1.4mmol/L) at 3-month, 6-month follow-up (if have enough follow-up data on lab test)	LDL-C goal attainment rate (<1.4mmol/L) at 3-month, 6-month follow-up (if have enough follow-up data on lab test)	3 months, 6 months

Collaborators and Investigators

• Sponsor: Yun Dai Chen
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Protease Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Serine Proteinase Inhibitors; PCSK9 Inhibitors; Ezetimibe; Alirocumab
• Other Study ID Numbers: 2023ESR0000153

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No