Effect of starting PCSK9 inhibitors in the hospital on heart outcomes in Chinese patients with acute coronary syndrome
Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients: A Database-based Retrospective Analysis
This study is trying to see if starting a new heart medication called alirocumab while in the hospital can help Chinese patients with acute coronary syndrome have better heart health compared to those who only get standard treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | Alirocumab, Evolocumab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06567418 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the impact of initiating alirocumab, a PCSK9 inhibitor, during hospitalization on major cardiovascular events in Chinese patients diagnosed with acute coronary syndrome (ACS). It compares outcomes between patients who received alirocumab combined with statins and those treated with statins alone. Data will be collected from the CCA Database-Chest Pain Center for ACS patients admitted between January 2021 and December 2023, ensuring all participants have at least one follow-up visit. The study seeks to determine if early intervention can effectively reduce the risk of cardiovascular events in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates include Chinese adults aged 18 and older diagnosed with acute coronary syndrome who received alirocumab during hospitalization.
Not a fit: Patients who have previously received Evolocumab or Inclisiran will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular outcomes for ACS patients through early intervention with PCSK9 inhibitors.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Dandan Li, Dr.
- Email: lidandan5564@163.com
- Phone: +86 13810545564
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.