Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome

Phase 3 Completed 400 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug.

Timeline

Start: 2021-06-24
Primary completion: 2024-08-07
Completion: 2024-08-07

Outcome

Met primary endpoint

registry analysis (superiority test); Inclisiran With Usual Care vs Usual Care; p < 0.001; LS mean difference -46.9 (97.5% CI -55.4 to -38.5); Mixed Models Analysis NCT04873934 ↗

registry analysis (superiority test); Inclisiran With Usual Care vs Usual Care; p < 0.001; Odds Ratio (OR) 5.42 (97.5% CI 3.29 to 8.91); Regression, Logistic NCT04873934 ↗

Publications

Knowlton KU, Navar AM, Anderson JL, Brown AS, Muhlestein JB, Kleeman K, Sarwat S, Abbas CA, Ramirez MA, Grines CL, Abo-Auda WS, Desai NR. Low-Density Lipoprotein Cholesterol Lowering With Inclisiran Plus Usual Care in Recent Acute Coronary Syndrome: VICTORION-INCEPTION, a Randomized, Controlled, Open-Label Trial. J Am Heart Assoc. 2026 May 19;15(10):e043655. doi: 10.1161/JAHA.125.043655. Epub 2026 May 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Inclisiran	Small interfering RNA (siRNA)	284 mg	—