Retrospective Analysis of the Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: alirocumab 75mg/2week, statin ± ezetimibe.
- Who it may be relevant to
- Registry conditions: Acute Coronary Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients: A Database-based Retrospective Analysis
Overview
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.
Interventions
- Drug alirocumab 75mg/2week
patients continually prescribed or stopped alirocumab treatment during the follow-up visit, which depend on physician's clinical decision and patient preference - Drug statin ± ezetimibe
patients will be censored at initiation of alirocumab during the follow up visit
Primary outcome measures
- The primary endpoint is the risk of MACE within 1 year of follow-up [Time frame: 12 months]
Secondary outcome measures (2)
- Percentage reduction of LDL-C levels at 1-month follow-up from baseline [Time frame: 1 month]
- Proportion of patient who achieved LDL-C goal (<1.4mmol/L) at 1-month follow-up [Time frame: 1 month]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Chinese PLA General Hospital — Beijing
Identifiers
NCT: NCT06567418 · 2023ESR0000153