STEMI - ST Elevation Myocardial InfarctionPhase 4AMUNDSENNCT04951856
Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI
A Phase 4 study testing Evolocumab 140 MG/ML in people with STEMI - ST Elevation Myocardial Infarction and NSTEMI - Non-ST Segment Elevation MI, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI
- What is being tested?
- Evolocumab 140 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,166 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2021to 22 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- > 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
Who cannot join
- Participant presenting with any of the following will not be included in the trial:
- Fibrinolysis treatment
- Planned CABG
- 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)
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- Known left ventricular ejection fraction < 30%
- 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
- 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
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
ACTION Group, Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC
Paris, 75013
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Previous randomized studies and several meta-analyses have shown a positive effect of high-dose statins pretreatment on peri-procedural Myocardial Infarction (MI) incidence with favorable trends on mortality in both Acute Coronary Syndrome (ACS) and stable Coronary Artery Disease patients.
Numerous epidemiological studies, Mendelian randomization studies, and Randomized Controled Trials have consistently demonstrated a log-linear relationship between the absolute changes in plasma LDL-C and the risk of Cardio-Vascular (CV) disease. The effect of LDL-C on the risk of a new CV event appears to be determined by the absolute magnitude, the duration of exposure to LDL-C and possibly the time to reach the recommended target of low LDL in ACS patients.
There are good reasons to believe that the Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors could provide additional benefits when used early in MI patients treated with PCI revascularization.
That's why the hypothesis of AMUNDSEN study is to demonstrate the superiority of a strategy using evolocumab before PCI in STEMI or NSTEMI patients versus standard of care (SOC) as described in the 2019 European Society of Cardiology / European Atherosclerosis Society (ESC/EAS) guidelines on dyslipidemia, to reach a Low-Density Lipoprotein Cholesterol (LDL-C) reduction of ≥ 50% from baseline and a LDL-C goal of <1.4 mmol/L (<55 mg/dL) at the end of the study (LDL targets of the 2019 ESC/EAS guidelines).
- Being tested
- Evolocumab 140 MG/ML, Standard of care (SOC)
- Keywords
- STEMI, NSTEMI, PCI, STATIN, EVOLOCUMAB, Anti-PCSK9, LDL-C
- Medical subject headings
- ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolocumab 140 MG/MLDrug
Also called Repatha
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 group | Role | What they receive |
|---|---|---|
| Evolocumab + SOC | Experimental | 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. Receives: Drug: Evolocumab 140 MG/ML |
| Standard of care (SOC) | Active comparator | management as recommended in ESC/EAS 2019 guidelines, within reimbursement criteria Receives: Drug: Standard of care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Monitoring of changes in LDL-C levels
Measured: From baseline and at 12 months
Composite endpoint of death (any cause) or any unplanned hospitalization for a CV reason
Main clinical endpoint obtained from reported adverse events occurred during participation to the study
Measured: Frome randomization to 12 months follow-up
Secondary outcomes (6)
LDL-C<40mg/dL at 12 months follow-up
Monitoring of changes in LDL-C levels (endpoints tested in hierarchical order)
Measured: from baseline and at 12 months follow-up
Composite of death (any cause), MI, stroke, unplanned revascularization
Data obtained from reported adverse events occurred during participation to the study (endpoints tested in hierarchical order)
Measured: from randomization to 12 months follow-up
Composite of death (any cause), MI, stroke
Data obtained from reported adverse events occurred during participation to the study (endpoints tested in hierarchical order)
Measured: from randomization to 12 months follow-up
Composite of death (any cause) or myocardial infarction
Data obtained from reported adverse events occurred during participation to the study (endpoints tested in hierarchical order)
Measured: from randomization to 12 months follow-up
Death (any cause)
Data obtained from reported adverse events occurred during participation to the study (endpoints tested in hierarchical order)
Measured: from randomization to 12 months follow-up
Death (cardiovascular)
Data obtained from reported adverse events occurred during participation to the study (endpoints tested in hierarchical order)
Measured: from randomization to 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start29 Sep 2021
- Primary completion22 May 2026 (estimated)
- Study completion22 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Action Research Group, Amgen
- Responsible party
- Sponsor
- Investigators
- Gilles MONTALESCOT, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951856
- Sponsor's protocol ID
- APHP201075
- Other IDs
- 2021-000573-80
- Acronym
- AMUNDSEN
- Status last verified
- Apr 2026
- First submitted
- 27 May 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Montalescot G, Ferrari E, Souteyrand G, Bouleti C, Range G, Batias-Moreau L, Chioccioli M, Picchi A, Dillinger JG, Esposito G, Patti G, Vincent F, Braik N, Ederhy S, Coste P, Hannachi S, Redjimi N, Zeitouni M, Duband B, Fourrier E, Guedeney P, Procopi N, Sabouret P, Diallo A, Brochard K, Chamam A, Vignolles N, Kerneis M, Silvain J, Jukema JW, Mach F, Cequier-Fillat A, Thiele H, Bartus S, Bolognese L, Vicaut E; AMUNDSEN Investigators of the ACTION Study Group. LDL Cholesterol Lowering With Evolocumab Before Percutaneous Coronary Intervention for Acute Myocardial Infarction: The AMUNDSEN Randomized Clinical Trial. JAMA. 2026 Aug 29. doi: 10.1001/jama.2026.17302. Online ahead of print.
PubMed 42666092
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04951856
- Acronym / sponsor ID
- AMUNDSEN / APHP201075
- Keywords
- STEMI, NSTEMI, PCI, STATIN, EVOLOCUMAB, Anti-PCSK9, LDL-C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,166 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Action Research Group, Amgen
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 22 May 2026 (estimated)
- Study completion
- 22 May 2028 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Previous randomized studies and several meta-analyses have shown a positive effect of high-dose statins pretreatment on peri-procedural Myocardial Infarction (MI) incidence with favorable trends on mortality in both Acute Coronary Syndrome (ACS) and stable Coronary Artery Disease patients.
Numerous epidemiological studies, Mendelian randomization studies, and Randomized Controled Trials have consistently demonstrated a log-linear relationship between the absolute changes in plasma LDL-C and the risk of Cardio-Vascular (CV) disease. The effect of LDL-C on the risk of a new CV event appears to be determined by the absolute magnitude, the duration of exposure to LDL-C and possibly the time to reach the recommended target of low LDL in ACS patients.
There are good reasons to believe that the Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors could provide additional benefits when used early in MI patients treated with PCI revascularization.
That's why the hypothesis of AMUNDSEN study is to demonstrate the superiority of a strategy using evolocumab before PCI in STEMI or NSTEMI patients versus standard of care (SOC) as described in the 2019 European Society of Cardiology / European Atherosclerosis Society (ESC/EAS) guidelines on dyslipidemia, to reach a Low-Density Lipoprotein Cholesterol (LDL-C) reduction of ≥ 50% from baseline and a LDL-C goal of <1.4 mmol/L (<55 mg/dL) at the end of the study (LDL targets of the 2019 ESC/EAS guidelines).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evolocumab + SOC | Experimental | Drug: Evolocumab 140 MG/MLInvestigational 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. |
| Standard of care (SOC) | Active comparator | Drug: Standard of care (SOC)management as recommended in ESC/EAS 2019 guidelines, within reimbursement criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participant meeting all of the following criteria will be considered for enrolment into the trial:
- 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
Key exclusion criteria (15 listed)
- Fibrinolysis treatment
- Planned CABG
- Ongoing hemodynamic instability defined as any of the following:
- Evidence of severe hepatobiliary disease: current active hepatic dysfunction or active biliary obstruction, decompensated cirrhosis or infectious/inflammatory hepatitis
- Active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evolocumab 140 MG/MLAlso: RepathaEvolocumab (Repatha®) 140 mg every two weeks: first subcutaneous injection at the time of randomization, before PCI, followings during 36 months. | Drug | Evolocumab + SOC |
| Standard of care (SOC)management as recommended in ESC/EAS 2019 guidelines, within reimbursement criteria | Drug | Standard of care (SOC) |
Primary outcome
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
Monitoring of changes in LDL-C levels
Composite endpoint of death (any cause) or any unplanned hospitalization for a CV reason
Time frame: Frome randomization to 12 months follow-up
Main clinical endpoint obtained from reported adverse events occurred during participation to the study
6 secondary outcomes
LDL-C<40mg/dL at 12 months follow-up
Time frame: from baseline and at 12 months follow-up
Composite of death (any cause), MI, stroke, unplanned revascularization
Time frame: from randomization to 12 months follow-up
Composite of death (any cause), MI, stroke
Time frame: from randomization to 12 months follow-up
Composite of death (any cause) or myocardial infarction
Time frame: from randomization to 12 months follow-up
Death (any cause)
Time frame: from randomization to 12 months follow-up
Death (cardiovascular)
Time frame: from randomization to 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 42666092Montalescot G, Ferrari E, Souteyrand G, Bouleti C, Range G, Batias-Moreau L, Chioccioli M, Picchi A, Dillinger JG, Esposito G, Patti G, Vincent F, Braik N, Ederhy S, Coste P, Hannachi S, Redjimi N, Zeitouni M, Duband B, Fourrier E, Guedeney P, Procopi N, Sabouret P, Diallo A, Brochard K, Chamam A, Vignolles N, Kerneis M, Silvain J, Jukema JW, Mach F, Cequier-Fillat A, Thiele H, Bartus S, Bolognese L, Vicaut E; AMUNDSEN Investigators of the ACTION Study Group. LDL Cholesterol Lowering With Evolocumab Before Percutaneous Coronary Intervention for Acute Myocardial Infarction: The AMUNDSEN Randomized Clinical Trial. JAMA. 2026 Aug 29. doi: 10.1001/jama.2026.17302. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles MONTALESCOT, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Evolocumab 140 MG/ML in people with STEMI - ST Elevation Myocardial Infarction and NSTEMI - Non-ST Segment Elevation MI, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04951856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.