Brief 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.

Conditions

• STEMI - ST Elevation Myocardial Infarction
• NSTEMI - Non-ST Segment Elevation MI

Intervention / Treatment

• Drug: Evolocumab 140 MG/ML
• Drug: Standard of care (SOC)

Primary Outcome Measures

• 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 (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 (Frome randomization to 12 months follow-up)
  Main clinical endpoint obtained from reported adverse events occurred during participation to the study

Countries

France

Locations and Investigators

• Hospital Universitario Central De Asturias, Oviedo, Spain
  • Alberto, Alperi Garcia
• Bellvitge University Hospital, Barcelona, Spain
  • Angel, Cequier
• Hospital General Universitario De Alicante, Alicante, Spain
  • Juan Miguel, Ruiz Nodar
• Hospital Universitario Marques De Valdecilla, Santander, Spain
  • Natalia, Royuela Martinez
• Hospital San Pedro, Logrono, Spain
  • Luis Javier, Alonso Perez
• Hospital Alvaro Cunqueiro, Vigo, Spain
  • Victor Alfonso, Jimenez Diaz
• Hospital De La Santa Creu I Sant Pau, Barcelona, Spain
  • Xavier, Garcia-Moll Marimon
• Krakowski Szpital Specjalistyczny IM. Jana Pawla II, Krakow, Poland
  • Jacek, Legutko
• Slaskie Centrum Chorob Serca W Zabrzu, Zabrze, Poland
  • Zbiniew, Kalarus
• Uniwersytecki Szpital Kliniczny W Poznaniu, Poznan, Poland
  • Maciej, Lesiak
• Szpital Uniwersytecki W Krakowie, Krakow, Poland
  • Stanislaw, Bartus
• Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Warsaw, Poland
  • Marcin, Grabowski
• Uniwersytecki Szpital Kliniczny W Opolu, Opole, Poland
  • Marek, Gierlotka
• Wojewódzki Szpital Specjalistyczny we Wrocławiu Ośrodek Badawczo-Rozwojowy, Wrocław, Poland
  • Tomasz, Roleder
• Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy, Bydgoszcz, Poland
  • Jacek, Kubica
• Otto Von Guericke Universitaet Magdeburg, Magdeburg, Germany
  • Rüdiger, Braun-Dullaeus
• Universitaetsklinikum Schleswig-Holstein AöR, Luebeck, Germany
  • Ingo, Eitel
• Universitaetsklinikum Jena KöR, Jena, Germany
  • Oliver, Weingärtner
• Herzzentrum Leipzig GmbH, Leipzig, Germany
  • Holger, Thiele
• Centre Hospitalier Yves Le Foll, Saint-Brieuc, France
  • Laurent, PAYOT
• Centre Hospitalier De Versailles, Le Chesnay Rocquencourt, France
  • Guillaume, GODEAU
• Centre Hospitalier Universitaire D'Angers, Angers, France
  • Fabrice, PRUNIER
• Clinique Du Pont De Chaume, Montauban, France
  • Thibaut, PETRONI
• Centre Hospitalier Metropole Savoie, Chambery, France
  • Laure, BATIAS-MOREAU
• Centre Hospitalier Universitaire De Nimes, Nimes Cedex 9, France
  • Guillaume, CAYLA
• Centre Hospitalier Universitaire De Poitiers, Poitiers, France
  • Claire, BOULETI
• Assistance Publique Hopitaux De Paris, Paris Cedex 10, France
  • Jean-Guillaume, DILLINGER
• Centre Hospitalier De Pau, Pau Cedex, France
  • Pierre, POUSTIS
• Assistance Publique Hopitaux De Paris, Paris Cedex 13, France
  • Gilles, MONTALESCOT
• CHRU De Nancy, Vandoeuvre Les Nancy Cedex, France
  • Batric, POPOVIC
• Hopital NOVO, Pontoise, France
  • Véronique, DECALF
• Centre Hospitalier D'Antibes Juan Les Pins, Antibes Cedex, France
  • Anne, BELLEMAIN-APPAIX
• Les Hopitaux Universitaires De Strasbourg, Strasbourg Cedex, France
  • Patrick, OHLMANN
• University Hospital Of Clermont-Ferrand, Clermont Ferrand Cedex 1, France
  • Géraud, SOUTEYRAND
• CHU Besancon, Besancon Cedex, France
  • François, SCHIELE
• Centre Hospitalier De Haguenau, Haguenau, France
  • Sabrina, UHRY
• Centre Hospitalier De Colmar, Colmar Cedex, France
  • Laszlo, LEVAI
• Centre Hospitalier Universitaire De Nice, Nice, France
  • Emilie, FERRARI
• Centre Hospitalier Universitaire De Toulouse, Toulouse Cedex 9, France
  • Meyer, ELBAZ
• Centre Hospitalier Universitaire De Lille, Lille, France
  • Eric, VAN BELLE
• Les Hopitaux De Chartres, Le Coudray, France
  • Gregoire, RANGE
• Centre Hospitalier Departemental Vendee, La Roche Sur Yon Cedex 9, France
  • Jacques, CHANPENG
• Centre Hospitalier Universitaire De Nantes, Saint Herblain, France
  • Julien, PLESSIS
• Centre Hospitalier De La Cote Basque, Bayonne, France
  • Jean Noel, LABEQUE
• Centre Hospitalier Regional Universitaire De Tours, Chambray Les Tours, France
  • Denis, ANGOULVANT
• Centre Hospitalier Universitaire De Caen Normandie, Caen Cedex 9, France
  • Farzin, BEYGUI
• Sant'Andrea Hospital, La Spezia, ASL5 Liguria, La Spezia, Italy
  • Alberto, Menozzi
• Azienda Ospedaliero-Universitaria Sant'Anna, Ferrara, Italy
  • Gianluca, Campo
• Azienda Sanitaria Locale Di Pescara, Pescara, Italy
  • Leonardo, Paloscia
• Azienda Unita' Sanitaria Locale Toscana Sud Est, Grosseto, Italy
  • Andrea, Picchi

And 4 other sites.

Study Officials

• Gilles MONTALESCOT, Pr (Principal Investigator) — Assistance Publique - Hôpitaux de Paris