NCT04951856Active, not recruitingPhase 4
Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI
Acute Myocardial Infarction Upbound to PCI 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 Study
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2166 (estimated)
- First submitted
- 27 May 2021
- Start date
- 29 Sept 2021
- Primary completion date
- 22 May 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Coronary artery disease
- NCT number
- NCT04951856
- EudraCT number
- 2021-000573-80
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 2166
- From 29 Sept 2021 to the primary completion date, 22 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously received or receiving evolocumab or any other therapy to inhibit PCSK9
- Currently receiving treatment in any other investigational device or drug trial, or less than 30 days since ending treatment on another investigational device or drug trial.
Other illness
- 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
Lab values
- Ongoing hemodynamic instability defined as any of the following:
- Killip Class III or IV
- Sustained and/or symptomatic hypotension (systolic blood pressure \< 80 mm Hg)
- Known left ventricular ejection fraction \< 30%
Other
- Participant presenting with any of the following will not be included in the trial:
- Fibrinolysis treatment
- Planned CABG
- Known sensitivity to any of the products or components to be administered during trial
- Female subject is pregnant, had a positive pregnancy test at inclusion, breastfeeding, or planning to become pregnant or breastfeed during treatment and for an additional 17 weeks after the last dose of IMP
- Participant likely to not be available to complete all protocol-required trial visits or procedures, and/or to comply with all required trial procedures to the best of the participant and investigator's knowledge.
Who the study is looking for
- Participant meeting all of the following criteria will be considered for enrolment into the trial:
- Diagnosis of STEMI or NSTEMI
- STEMI defined as:
- symptoms of acute MI of at least 30 min AND
- within the previous 24 hours with new persistent ST-segment elevation ≥1 mm in ≥2 continuous 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 ischemic symptoms of ≥10 minutes duration at rest ≤48 hours prior to entry into the trial with no evidence of persistent ST-segment elevation and with an elevated troponin (≥ the upper limit of normal according to local laboratory norms), AND
- indication for a coronary angiogram within 72hrs AND
- indication for PCI AND
- at least one the following high-risk characteristics: Diabetes Peripheral Artery Disease Multivessel (≥ 2 or LM) disease on the coronary angiogram History of MI or stroke without sequels prior to randomization eGFR: 15 to 45 mL/min/1.73 m2 calculated with MDRD formula at randomization
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ACTION Group, Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.