Clinical trial NCT06567418: Retrospective Analysis of the Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients
Official title: Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients: A Database-based Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2024-08-22
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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: 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.

Primary outcomes:
measure: The primary endpoint is the risk of MACE within 1 year of follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Percentage reduction of LDL-C levels at 1-month follow-up from baseline
timeFrame: 1 month
measure: Proportion of patient who achieved LDL-C goal (<1.4mmol/L) at 1-month follow-up
timeFrame: 1 month
Other outcomes:
measure: Association between ACS pathway optimization participation and MACE within 1 year follow-up
timeFrame: 12 months
measure: Association between ACS pathway optimization participation and LDL-C goal attainment rate at 1-month follow-up
timeFrame: 1 month
measure: Percentage reduction of LDL-C levels at 3-month, 6-month follow-up from baseline (if have enough follow-up data on lab test)
timeFrame: 3 months, 6 months
measure: LDL-C goal attainment rate (<1.4mmol/L) at 3-month, 6-month follow-up (if have enough follow-up data on lab test)
timeFrame: 3 months, 6 months
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References: