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

Study acronym: AMUNDSEN
StatusActive, Not Recruiting
PhasePhase 4
Started2021-09-29
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 13, 2026 (before its estimated May 22, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-04-08
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v6
Eligibility criteria-15 characters
Inclusion Criteria: Participant meeting all of the following criteria will be considered for enrolment into the trial: Male or female Diagnosis of STEMI or NSTEMI STEMI defined as: symptoms of a [...]
Secondary endpoints10 to 6 entries
LDL-C reduction of ≥ 50% from baseline and a final LDL-C of <1.4 mmol/L (<55 mg40mg/dL) at 12 months follow-up, country by country. LDL-C reductionComposite of ≥death 50%(any andcause), anMI, LDL-Cstroke, goalunplanned revascularization Composite of <1.4 mmol/Ldeath (<55any mg/dLcause)and other relevant thresholds: <70, <40MI, and <20 mg/dLstroke Percent change in levelsComposite of LDL-C Timedeath to(any achieve LDL-C target Time averaged LDL-C change Change on total cholesterol Change on HDL-C Change on triglycerides Change on non-HDL-C Lipoprotein(acause) or myocardial infarction Death (Lpa [...] [...]
Primary endpoints1 to 2 entries
Composite endpoint of death (any cause) or any unplanned hospitalization for a CV reason LDL-C reduction of ≥ 50% from baseline and a final LDL-C of <1.4 mmol/L (<55 mg/dL) at 12 months follow-up.
2025-12-09
Recruiting→Active, Not Recruiting Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-09-29→2026-05-22
Completion date2027-09-29→2028-05-22
Study sitesdetails revised at 1 of 1 site
2025-01-27
Study Identification, Study Status, Oversight, IPDSharing v4
Re-verified, no change to tracked fields
2024-06-19
Study Status, Study Design, Outcome Measures, Eligibility v3
Primary completion date2024-09-29→2025-09-29
Completion date2024-09-29→2027-09-29
Enrollment target1666→2166
Eligibility criteria+134 characters
Inclusion Criteria: Participant meeting all of the following criteria will be considered for enrolment into the studytrial: Male or female Diagnosis of STEMI or NSTEMI STEMI defined [...] s ECG leads AND an indication for primary PCI AND > 55 years reported by the patient NSTEMI defined as: Age≥18 a history of chest discomfort or [...] minutes duration at rest ≤48 hours prior to entry into the studytrial with no evidence of persistent ST-segment elevation and wit [...] rated dose, as part of the standard of care at randomization, means Intent to treat with statin and the patient will receive his first dose as s [...] [...]
Secondary endpoints9 to 10 entries
LDL-C reduction of ≥ 50% and an LDL-C goal of <1.4 mmol/L (<55 mg/dL)and other relevant thresholds: <70, <40, and <20 mg/dL Lipoprotein(a) (Lp(a)
2024-04-10
Study Status v2
Primary completion date2023-09-29→2024-09-29
Completion date2023-09-29→2024-09-29
2021-10-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-07-15→2023-09-29
Completion date2023-07-15→2023-09-29
Start dateestimated 2021-07-01→confirmed 2021-09-29
Study sitesdetails revised at 1 of 1 site
2021-06-26
Original filing
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.
Trial Details
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