Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI
Status:
Recruiting
Trial end date:
2023-09-29
Target enrollment:
Participant gender:
Summary
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.
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.