Trial results for the study investigating inclisiran in participants with a recent acute coronary syndrome (ACS) were posted on ClinicalTrials.gov on 2025-08-21. The study showed that inclisiran with usual care led to a -45.6% least squares mean percent change from baseline in LDL-C at Day 330, compared to a 1.4% change with usual care alone. Additionally, 66.7% of participants in the inclisiran group achieved LDL-C below 70 mg/dL at Day 330, versus 28.1% in the usual care group.
Background
The study, titled "Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome," aimed to evaluate the effectiveness of a systematic LDL-C management pathway including treatment with inclisiran. This pathway was for participants who had experienced a recent acute coronary syndrome (ACS) and had an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug.
Trial design
The study (NCT04873934) was a Phase 3 trial that enrolled 400 participants. It investigated inclisiran in individuals diagnosed with acute coronary syndrome. Participants were treated with either inclisiran with usual care or usual care alone.
Key results
The trial results demonstrated significant differences in LDL-C reduction and target achievement between the inclisiran with usual care group and the usual care group.
- For "Percent Change From Baseline to Day 330 in LDL-C":
- Inclisiran With Usual Care group showed a least squares mean change of -45.6%.
- Usual Care group showed a least squares mean change of 1.4%.
- For "Achievement of LDL-C < 70 mg/dL at Day 330":
- 66.7% of participants in the Inclisiran With Usual Care group achieved this target.
- 28.1% of participants in the Usual Care group achieved this target.
- For "Absolute Change From Baseline in LDL-C" (least squares mean):
- At Day 90: -44.2 mg/dL for Inclisiran With Usual Care vs. -2.2 mg/dL for Usual Care.
- At Day 270: -34.6 mg/dL for Inclisiran With Usual Care vs. -3.8 mg/dL for Usual Care.
- At Day 330: -41.2 mg/dL for Inclisiran With Usual Care vs. -3.5 mg/dL for Usual Care.
- For "Average Percent Change From Baseline in LDL-C Levels":
- Inclisiran With Usual Care group showed a least squares mean change of -44.3%.
- Usual Care group showed a least squares mean change of 2.4%.
Key analyses further supported these findings:
- A Mixed Models Analysis for "Percent Change From Baseline to Day 330 in LDL-C" showed an LS mean difference of -46.9 (97.5% CI: -55.4 to -38.5) with a p-value of 0.001.
- A Logistic Regression for "Achievement of LDL-C < 70 mg/dL at Day 330" showed an Odds Ratio (OR) of 5.42 (97.5% CI: 3.29 to 8.91) with a p-value of 0.001.
- For "Absolute Change From Baseline in LDL-C", Mixed Models Analyses showed LS mean differences at:
- Day 90: -42.0 (95.0% CI: -47.3 to -36.7) with a p-value of 0.001.
- Day 270: -30.8 (95.0% CI: -37.4 to -24.3) with a p-value of 0.001.
- Day 330: -37.7 (95.0% CI: -44.5 to -31.0) with a p-value of 0.001.
- An ANCOVA for "Average Percent Change From Baseline in LDL-C Levels" showed an LS mean difference of -46.7 (95.0% CI: -52.7 to -40.8) with a p-value of 0.001.
What this means
The results from this Phase 3 trial indicate that adding inclisiran to usual care significantly improves LDL-C reduction and the achievement of target LDL-C levels (< 70 mg/dL) in patients who have recently experienced an acute coronary syndrome and have elevated LDL-C despite statin therapy. The substantial percentage and absolute reductions in LDL-C, alongside the increased proportion of patients reaching the therapeutic goal, suggest that inclisiran could be an important therapeutic option for managing hypercholesterolemia in this high-risk population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04873934, titled "Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome," were posted on 2025-08-21 on clinicaltrials.gov.