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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYun Dai Chen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients who received Evolocumab treatment at any time.

Patients who received Inclisiran treatment at any time.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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

Treatment groups

10,000 Participants
are divided into 2 treatment groups
Group A: intervention group1 intervention
Group B: control group1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 months

Secondary outcomes

1

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

Time frame
1 month
2

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

Time frame
1 month

Other outcomes

1

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

Time frame
12 months
2

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

Time frame
1 month
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)

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
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)

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

Sponsors and contacts

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Yun Dai Chen

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Sanofi

Collaborator