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NCT Number: NCT06567418

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location status: Recruiting

Location contact

Dandan Li, MD

CONTACT

[email protected]

13810545564 ext. 86

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. The primary endpoint is the risk of MACE within 1 year of follow-up

    Time frame: 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 outcomes

  1. Percentage reduction of LDL-C levels at 1-month follow-up from baseline

    Time frame: 1 month

    Percentage reduction of LDL-C levels at 1-month follow-up from baseline

  2. Proportion of patient who achieved LDL-C goal (<1.4mmol/L) at 1-month follow-up

    Time frame: 1 month

    Proportion of patient who achieved LDL-C goal (<1.4mmol/L) at 1-month follow-up

Other outcomes

  1. Association between ACS pathway optimization participation and MACE within 1 year follow-up

    Time frame: 12 months

    Association between ACS pathway optimization participation and MACE within 1 year follow-up

  2. Association between ACS pathway optimization participation and LDL-C goal attainment rate at 1-month follow-up

    Time frame: 1 month

    Association between ACS pathway optimization participation and LDL-C goal attainment rate at 1-month follow-up

  3. Percentage reduction of LDL-C levels at 3-month, 6-month follow-up from baseline (if have enough follow-up data on lab test)

    Time frame: 3 months, 6 months

    Percentage reduction of LDL-C levels at 3-month, 6-month follow-up from baseline (if have enough follow-up data on lab test)

  4. LDL-C goal attainment rate (<1.4mmol/L) at 3-month, 6-month follow-up (if have enough follow-up data on lab test)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Dandan Li, Dr.

CONTACT

[email protected]

+86 13810545564

Sponsors and collaborators

Lead sponsor

Yun Dai Chen

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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