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
Apply to this trial

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

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

Related Studies