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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-
EU CTIS ID: 2024-518195-31-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female
- Diagnosis of 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
- or, with a non-ST-segment elevation myocardial infarction (NSTEMI) defined by : Angiography performed within 72 hours, AND Indication for percutaneous coronary intervention, AND Presenting at least one of the following risk factors: Diabetes, Peripheral arterial disease, Multitruncular disease (≥ 2 or common trunk) confirmed by angiography, Previous myocardial infarction or stroke without sequelae prior to randomisation, eGFR creatinine clearance: 15 to 45 mL/min/1.73 m² calculated according to the MDRD formula at randomisation.
- Statin at the maximum tolerated dose as part of standard management, i.e. intention to treat with a statin as soon as possible at randomisation
- Inform consent obtained in writing at enrolment in the trial
You likely can't join if
- Fibrinolytic treatment
- Participating in another clinical trial with other investigational treatments or devices within 30 days prior to inclusion in this trial, or already included in a trial.
- Unavailable and/or non-compliant to attend follow-up visits and to follow all procedures required by the trial.
- Scheduled bypass
- Current haemodynamic instability defined by either : Killip III or IV, Symptomatic and/or sustained hypotension (systolic pressure <80 mmHg), Known left ventricular ejection fraction < 30%.
- Evidence of severe hepatobiliary disease: active liver dysfunction or active biliary obstruction, decompensated cirrhosis or infectious/inflammatory hepatitis.
See the full eligibility criteria
- Male or female
- Diagnosis of 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
- or, with a non-ST-segment elevation myocardial infarction (NSTEMI) defined by : Angiography performed within 72 hours, AND Indication for percutaneous coronary intervention, AND Presenting at least one of the following risk factors: Diabetes, Peripheral arterial disease, Multitruncular disease (≥ 2 or common trunk) confirmed by angiography, Previous myocardial infarction or stroke without sequelae prior to randomisation, eGFR creatinine clearance: 15 to 45 mL/min/1.73 m² calculated according to the MDRD formula at randomisation.
- Statin at the maximum tolerated dose as part of standard management, i.e. intention to treat with a statin as soon as possible at randomisation
- Inform consent obtained in writing at enrolment in the trial
- Fibrinolytic treatment
- Participating in another clinical trial with other investigational treatments or devices within 30 days prior to inclusion in this trial, or already included in a trial.
- Unavailable and/or non-compliant to attend follow-up visits and to follow all procedures required by the trial.
- Scheduled bypass
- Current haemodynamic instability defined by either : Killip III or IV, Symptomatic and/or sustained hypotension (systolic pressure <80 mmHg), Known left ventricular ejection fraction < 30%.
- Evidence of severe hepatobiliary disease: active liver dysfunction or active biliary obstruction, decompensated cirrhosis or infectious/inflammatory hepatitis.
- Active cancer
- Comorbidity limiting life expectancy to less than 12 months
- Previous or ongoing evolocumab or other anti-PCSK9 therapy
- Known hypersensitivity to any component of the trial treatment
- Pregnant (with a positive pregnancy test at inclusion), breast-feeding or planning to have children or breast-feed during treatment and for a period of 17 weeks after the end of treatment in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.