Evaluating early lipid-lowering therapy in acute coronary syndrome patients

Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients

This study is testing if starting a new cholesterol-lowering treatment early can help Chinese patients with acute coronary syndrome have better heart health and lower cholesterol levels compared to other treatments.

Quick facts

• Study type: Observational
• Enrollment: 6000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06738758 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effects of early initiation of PCSK9 inhibitor therapy on lipid levels and cardiovascular outcomes in Chinese patients hospitalized for acute coronary syndrome (ACS). Researchers will compare three different lipid-lowering strategies: PCSK9 inhibitor therapy, statin plus Ezetimibe/Hybutimibe, and statin monotherapy. The primary focus is on achieving guideline-recommended lipid levels within one year and reducing the incidence of adverse cardiovascular events. The study will involve real-world data collection from multiple centers in China.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older hospitalized for acute coronary syndrome with specific LDL-C levels.

Not a fit: Patients with severe comorbidities, recent PCSK9 inhibitor therapy, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved management of lipid levels and reduced cardiovascular events in ACS patients.

How similar studies have performed: Other studies have shown promise in using PCSK9 inhibitors for lipid management, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years.
2. This hospitalization for ACS, which includes ST-segment elevation MI (STEMI), non-ST-segment elevation MI (NSTEMI), or unstable angina pectoris (UA) with a GRACE score of intermediate to high risk.
3. Written informed consent must be obtained from eligible patients prior to study enrollment.
4. LDL-C ≥1.8 mmol/L in patients using statin; LDL-C ≥2.6 mmol/L in those not taking statin in the last 4 weeks.

Exclusion Criteria:

1. Received PCSK9 inhibitor therapy within 3 months.
2. Patient has any life-threatening severe disease, including severe liver injury and persistent elevation of serum transaminases, and severe renal failure.
3. Patient has a history of renal or cardiac transplantation.
4. The patient is a pregnant or breastfeeding woman or a woman planning to become pregnant.

Patients judged by the investigator to be unsuitable for enrollment.

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Dandan Li, professor

Conditions Acute Coronary Syndromes; PCSK9 Inhibitor; Lipid compliance time and rate; First cardiovascular event