Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to… (NCT04951856) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI
France2,166 participantsStarted 2021-09-29
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis of STEMI or NSTEMI
. Statin at maximal tolerated 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 soon as possible after admission
. Informed consent obtained in writing at enrolment into the trial
Exclusion criteria
. Fibrinolysis treatment
. Planned CABG
. Ongoing hemodynamic instability defined as any of the following:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for people who've had a heart attack and undergone PCI — given my situation, is my case similar enough to what this trial studied that its findings might be relevant to my treatment decisions?
2The trial is testing whether evolocumab (a PCSK9 inhibitor injection) can get LDL cholesterol below 55 mg/dL within 12 months after a heart attack — how does that aggressive LDL target compare to what you'd aim for with my current or planned medications?
3Since this is a Phase 4 trial — meaning evolocumab is already approved — what does the existing safety data on this drug look like, and are there risks I should know about before considering it as part of my post-heart attack care?
4The trial measures deaths and unplanned hospitalizations for cardiovascular reasons over 12 months — based on what's been observed in similar studies, does adding a PCSK9 inhibitor like evolocumab on top of standard statin therapy actually reduce those kinds of events for someone in my position?
5This study is no longer enrolling new patients — are there similar ongoing trials or is evolocumab now standard enough that you'd consider prescribing it for me directly, and how would that compare to just adjusting my statin dose?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: From baseline and at 12 months
2
Composite endpoint of death (any cause) or any unplanned hospitalization for a CV reason
Timeframe: Frome randomization to 12 months follow-up
. Evidence of severe hepatobiliary disease: current active hepatic dysfunction or active biliary obstruction, decompensated cirrhosis or infectious/inflammatory hepatitis
. Active malignancy
. A comorbid condition with an estimated life expectancy of ≤ 12 months
. Previously received or receiving evolocumab or any other therapy to inhibit PCSK9
. Known sensitivity to any of the products or components to be administered during trial