Trial results for a Phase 2 study investigating evolocumab in patients with Acute Coronary Syndrome were posted on ClinicalTrials.gov on 2025-11-24. The study demonstrated that evolocumab achieved a median percent change in LDL-Cholesterol of -68.78%, compared to -27.58% for placebo.
Background
Acute Coronary Syndrome (ACS) is characterized by significantly increased vascular and myocardial inflammation, which correlates with LDL-C levels and adverse outcomes in post-ACS patients. Serum proprotein convertase subtilisin/kerin type 9 (PCSK9) levels are also elevated in ACS, potentially increasing LDL-C and inducing vascular inflammation. Evolocumab is a PCSK9 antibody currently approved to lower LDL-C in certain patient populations.
Trial design
The study (NCT03515304) was a Phase 2, completed trial that enrolled 60 participants. It investigated evolocumab in patients diagnosed with Acute Coronary Syndrome. Participants were randomized to receive either evolocumab or placebo.
Key results
The trial results included several key measurements:
- For "Percent Change in LDL-Cholesterol":
- The evolocumab group showed a median percent change of -68.78%.
- The placebo group showed a median percent change of -27.58%.
- For "Change From Baseline in Target to Background Ratio Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Scans":
- The evolocumab group had a mean change of -26.7 (Standard Deviation: 20.4).
- The placebo group had a mean change of -10.4 (Standard Deviation: 36.2).
- For "Left Ventricular Volume as Assessed by Echocardiography", multiple measurements were reported:
- In one assessment, the evolocumab group had a mean of 67.80 ml (Standard Deviation: 33.69), and the placebo group had a mean of 59.45 ml (Standard Deviation: 30.64).
- In another assessment, the evolocumab group had a mean of 54.57 ml (Standard Deviation: 23.05), and the placebo group had a mean of 55.63 ml (Standard Deviation: 22.41).
- A further assessment showed the evolocumab group with a mean of 62.53 ml (Standard Deviation: 35.78), and the placebo group with a mean of 51.12 ml (Standard Deviation: 29.28).
- Another assessment reported the evolocumab group with a mean of 117.4 ml (Standard Deviation: 33.63), and the placebo group with a mean of 112.0 ml (Standard Deviation: 33.03).
A t-test (2 sided) analysis for an unspecified outcome yielded a p-value of 0.2497.
What this means
The results indicate that evolocumab significantly reduced LDL-Cholesterol levels in patients with Acute Coronary Syndrome compared to placebo. The observed reduction in LDL-C of -68.78% with evolocumab suggests a potential benefit in managing lipid profiles in this high-risk population. While other measurements like changes in FDG PET scans also showed differences, the overall implications for myocardial inflammation and left ventricular volume require further investigation, especially given the non-significant p-value reported for one analysis.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03515304, titled "Evolocumab in Acute Coronary Syndrome," were posted on 2025-11-24 on clinicaltrials.gov.