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

NCT ID: NCT06567418

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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intervention group

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

alirocumab 75mg/2week

Intervention Type DRUG

patients continually prescribed or stopped alirocumab treatment during the follow-up visit, which depend on physician's clinical decision and patient preference

control group

patients were treated with statin ± ezetimibe only

statin ± ezetimibe

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

statin ± ezetimibe

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Yun Dai Chen

OTHER

Sponsor Role lead

Responsible Party

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Yun Dai Chen

professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dandan Li, Dr.

Role: CONTACT

+86 13810545564

Facility Contacts

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Dandan Li, MD

Role: primary

13810545564 ext. 86

Other Identifiers

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2023ESR0000153

Identifier Type: -

Identifier Source: org_study_id

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