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

Sponsor
Yun Dai Chen
Study ID
NCT06567418
Status
Recruiting
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Conditions

  • Acute Coronary Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • alirocumab 75mg/2week — DRUG
    patients continually prescribed or stopped alirocumab treatment during the follow-up visit, which depend on physician's clinical decision and patient preference
  • statin ± ezetimibe — DRUG
    patients will be censored at initiation of alirocumab during the follow up visit

Study Details

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.

Key Dates

First listed
Aug 22, 2024
Start date
Aug 1, 2024
Status verified
Aug 2024
Primary completion
Aug 31, 2024
Completion
Jan 31, 2025

Study Design

Enrollment
10,000 participants (estimated)

Arms

  • Arm: intervention group
    patients were treated with alirocumab 75mg combined with statin ± ezetimibe
  • Arm: control group
    patients were treated with statin ± ezetimibe only

Primary Outcome Measure

The primary endpoint is the risk of MACE within 1 year of follow-up [ Time Frame: 12 months ]

Central Contacts

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