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

NCT06567418 | Recruiting DMC

• 1 other identifier: 2023ESR0000153
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

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

  12 months

Secondary Outcomes (2)

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

  1 month

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

  1 month

Other Outcomes (4)

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

  12 months

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

  1 month

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

  3 months, 6 months

Study Arms (2)

intervention group

patients were treated with alirocumab 75mg combined with statin ± ezetimibe

Drug: alirocumab 75mg/2week

control group

patients were treated with statin ± ezetimibe only

Drug: statin ± ezetimibe

Interventions

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

intervention group

statin ± ezetimibe DRUG

patients will be censored at initiation of alirocumab during the follow up visit

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who received Evolocumab treatment at any time.
• Patients who received Inclisiran treatment at any time.

Sponsors & Collaborators

• Yun Dai Chen: lead
• Sanofi: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

alirocumab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Dandan Li, Dr.

CONTACT

+86 13810545564; lidandan5564@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: August 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: January 31, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

CN (1)