Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI

AMUNDSEN-real is a phase IV, international (7 European countries), multicenter, controlled, open label study randomized, in 2 parallel groups of patients with a diagnosis of STEMI or NSTEMI with an indication for PCI, using the PROBE study design (Prospective Randomised Open, Blinded Endpoint). The objective of this study is to demonstrate the superiority of evolocumab versus standard of care in reaching a LDL-C reduction of ≥ 50% from baseline and a LDL-C goal of \<1.4 mmol/L (\<55 mg/dL) at 12 months follow-up on the overall population. The primary clinical objective is to demonstrate the superiority of evolocumab versus standard of care on the composite endpoint of death or any unplanned hospitalization for a CV reason at 12 months. Central randomization uses an IWRS. Stratification is by center and stratum with random block size, generated according to the procedures of the sponsor, by a statistician not involved in the study.

NCT Number	NCT04951856
Lead Sponsor	Assistance Publique - Hôpitaux de Paris Collaborators: Action Research Group, Amgen
Conditions	STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI
Enrollment	2,166 participants
Start Date	2021-09-29
Primary Completion	2026-05-22 (estimated)
Study Completion	2028-05-22 (estimated)
Updated on ClinicalTrials.gov	2026-04-13