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

Y

Yun Dai Chen

Status

Enrolling

Conditions

Acute Coronary Syndrome

Treatments

Drug: alirocumab 75mg/2week
Drug: statin ± ezetimibe

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT06567418
2023ESR0000153

Details and patient eligibility

About

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.

Enrollment

10,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

10,000 participants in 2 patient groups

intervention group
Description:
patients were treated with alirocumab 75mg combined with statin ± ezetimibe
Treatment:
Drug: alirocumab 75mg/2week
control group
Description:
patients were treated with statin ± ezetimibe only
Treatment:
Drug: statin ± ezetimibe

Trial contacts and locations

1

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Central trial contact

Dandan Li, Dr.

Data sourced from clinicaltrials.gov

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