Skip to content

AMUNDSEN - Acute Myocardial infarction Upbound to percutaneous coronary intervention, immediately (STEMI) or in the Next three Days (NSTEMI), and randomized to Subcutaneous Evolocumab or Normal strategies to reach guidelines LDL objectives in the real-world - The AMUNDSEN-real trial-

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518195-31-00
Acronym
APHP201075
Enrollment
2166
Registered
2024-11-12
Start date
2021-09-29
Completion date
Unknown
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute myocardial infarction

Brief summary

The primary endpoint is a reduction in LDL-C levels ≥ 50% from baseline and an LDL-C level < 1.4 mmol/L at 12 months follow-up., LDL-C levels will be assessed at follow-up visits at 6 and 22 weeks and 12 months after randomisation. (At 38 weeks, 16, 20, 28 and 32 months post-randomisation, only if data are available)., The primary clinical endpoint is the composite endpoint of death (any cause) or any unplanned hospitalization for a CV reason at 12 months

Detailed description

LDL-C<40, mg/dL at 12 months follow-up, Composite of death (any cause), myocardial infarction, stroke, unplanned revascularization at 12 months follow-up, Composite of death (any cause) or myocardial infarction at 12 months follow-up, Death (any cause) at 12 months follow-up, Death (cardiovascular) at 12 months follow-up, Composite of death (any cause), myocardial infarction, stroke at 12 months follow-up

Interventions

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary endpoint is a reduction in LDL-C levels ≥ 50% from baseline and an LDL-C level < 1.4 mmol/L at 12 months follow-up., LDL-C levels will be assessed at follow-up visits at 6 and 22 weeks and 12 months after randomisation. (At 38 weeks, 16, 20, 28 and 32 months post-randomisation, only if data are available)., The primary clinical endpoint is the composite endpoint of death (any cause) or any unplanned hospitalization for a CV reason at 12 months

Secondary

MeasureTime frame
LDL-C<40, mg/dL at 12 months follow-up, Composite of death (any cause), myocardial infarction, stroke, unplanned revascularization at 12 months follow-up, Composite of death (any cause) or myocardial infarction at 12 months follow-up, Death (any cause) at 12 months follow-up, Death (cardiovascular) at 12 months follow-up, Composite of death (any cause), myocardial infarction, stroke at 12 months follow-up

Countries

France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026