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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT04951856
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • NSTEMI - Non-ST Segment Elevation MI
  • STEMI - ST Elevation Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab 140 MG/ML — DRUG
    Evolocumab (Repatha®) 140 mg every two weeks: first subcutaneous injection at the time of randomization, before PCI, followings during 36 months.
  • Standard of care (SOC) — DRUG
    management as recommended in ESC/EAS 2019 guidelines, within reimbursement criteria

Study Details

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.

Key Dates

Start date
Sep 29, 2021
Status verified
Apr 2026
Primary completion
May 22, 2026
Completion
May 22, 2028

Study Design

Enrollment
2,166 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Evolocumab + SOC
    Investigational Product is open label Evolocumab (Repatha®) 140 mg every two weeks: first subcutaneous injection at the time of randomization, before PCI, followings during 36 months.
  • Active Comparator: Standard of care (SOC)
    management as recommended in ESC/EAS 2019 guidelines, within reimbursement criteria

Primary Outcome Measure

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 [ Time Frame: From baseline and at 12 months ]

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