Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 4
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2021
septembre 2027
05 avril 2025
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.
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital La Pitié-Salpêtrière | MONTALESCOT Gilles | 18/04/2025 07:55:36 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | MONTALESCOT Gilles | 18/04/2025 07:55:36 | Contacter | ||
| HOPITAL NOVO | DECALF Véronique | 14/02/2025 09:03:12 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| ACTION Group, Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC - 75013 - Paris - France | Gilles MONTALESCOT, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
Participant meeting all of the following criteria will be considered for enrolment into
the trial:
1. Male or female
2. 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
3. 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
4. Informed consent obtained in writing at enrolment into the trial
Participant meeting all of the following criteria will be considered for enrolment into
the trial:
1. Male or female
2. 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
3. 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
4. Informed consent obtained in writing at enrolment into the trial
Participant presenting with any of the following will not be included in the trial:
1. Fibrinolysis treatment
2. Planned CABG
3. 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%
4. Evidence of severe hepatobiliary disease: current active hepatic dysfunction or
active biliary obstruction, decompensated cirrhosis or infectious/inflammatory
hepatitis
5. Active malignancy
6. A comorbid condition with an estimated life expectancy of ≤ 12 months
7. Previously received or receiving evolocumab or any other therapy to inhibit PCSK9
8. Known sensitivity to any of the products or components to be administered during
trial
9. 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
10. 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.
11. 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.