Clinical trial • Phase IV • Cardiology
Evolocumab for Acute myocardial infarction
Phase IV trial of Evolocumab for Acute myocardial infarction.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Acute myocardial infarction
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 14-10-2024
- First CTIS Authorization Date
- 11-11-2024
Trial design
Randomised, evolocumab (repatha 140 mg solution for injection in pre-filled pen) subcutaneous versus standard of care / "normal strategies" to reach guideline ldl objectives. specific dosing schedule not specified in the ctis summary.-controlled Phase IV trial in Spain, Poland, Germany and others.
- Randomised
- Yes
- Comparator
- Evolocumab (Repatha 140 mg solution for injection in pre-filled pen) subcutaneous versus standard of care / "normal strategies" to reach guideline LDL objectives. Specific dosing schedule not specified in the CTIS summary.
- Real World Control
- Yes
- Target Sample Size
- 433
- Trial Duration For Participant
- 365
Eligibility
Recruits 433 Vulnerable population not selected. The trial enrols adults; informed consent is required: "Inform consent obtained in writing at enrolment in the trial". No assent/parental consent procedures or paediatric consent arrangements are described..
- Pregnancy Exclusion
- 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.
- Vulnerable Population
- Vulnerable population not selected. The trial enrols adults; informed consent is required: "Inform consent obtained in writing at enrolment in the trial". No assent/parental consent procedures or paediatric consent arrangements are described.
Inclusion criteria
- {"criterion_text":"- Male or female\n- 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\n- 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.\n- 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\n- Inform consent obtained in writing at enrolment in the trial"}
Exclusion criteria
- {"criterion_text":"- Fibrinolytic treatment\n- 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.\n- Unavailable and/or non-compliant to attend follow-up visits and to follow all procedures required by the trial.\n- Scheduled bypass\n- 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%.\n- Evidence of severe hepatobiliary disease: active liver dysfunction or active biliary obstruction, decompensated cirrhosis or infectious/inflammatory hepatitis.\n- Active cancer\n- Comorbidity limiting life expectancy to less than 12 months\n- Previous or ongoing evolocumab or other anti-PCSK9 therapy\n- Known hypersensitivity to any component of the trial treatment\n- 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."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is a reduction in LDL-C levels ≥ 50% from baseline and an LDL-C level < 1.4 mmol/L at 12 months follow-up.","definition_or_measurement_approach":"LDL-C measured and compared to baseline at 12 months follow-up to assess ≥50% reduction and absolute LDL-C < 1.4 mmol/L."}
- {"endpoint_text":"- LDL-C levels will be assessed at follow-up visits at 6 and 22 weeks and 12 months after randomisation. (At 38 weeks, 16, 20, 28 and 32 months post-randomisation, only if data are available).","definition_or_measurement_approach":"Scheduled LDL-C assessments at 6 weeks, 22 weeks and 12 months post-randomisation (and at additional later timepoints if data available) to evaluate lipid outcomes."}
- {"endpoint_text":"- The primary clinical endpoint is the composite endpoint of death (any cause) or any unplanned hospitalization for a CV reason at 12 months","definition_or_measurement_approach":"Composite clinical outcome (all-cause death OR any unplanned cardiovascular hospitalization) assessed at 12 months post-randomisation."}
Secondary endpoints
- {"endpoint_text":"- LDL-C<40, mg/dL at 12 months follow-up","definition_or_measurement_approach":"LDL-C measured at 12 months; assessment of whether LDL-C <40 mg/dL."}
- {"endpoint_text":"- Composite of death (any cause), myocardial infarction, stroke, unplanned revascularization at 12 months follow-up","definition_or_measurement_approach":"Composite clinical outcome assessed at 12 months post-randomisation."}
- {"endpoint_text":"- Composite of death (any cause) or myocardial infarction at 12 months follow-up","definition_or_measurement_approach":"Composite (all-cause death OR myocardial infarction) assessed at 12 months."}
- {"endpoint_text":"- Death (any cause) at 12 months follow-up","definition_or_measurement_approach":"All-cause mortality status assessed at 12 months."}
- {"endpoint_text":"- Death (cardiovascular) at 12 months follow-up","definition_or_measurement_approach":"Cardiovascular-specific mortality assessed at 12 months."}
- {"endpoint_text":"- Composite of death (any cause), myocardial infarction, stroke at 12 months follow-up","definition_or_measurement_approach":"Composite outcome of death, MI, or stroke assessed at 12 months."}
Recruitment
- Planned Sample Size
- 433
- Recruitment Window Months
- 78
- Consent Approach
- Informed consent obtained in writing at enrolment from participants (adults). Subject information and informed consent form (L1) available for adults; protocol and ICF materials available in multiple languages (English, French, Polish, German, Italian as indicated by protocol synopses and ICF documents). No assent or minor-specific consent procedures described.
Geography
- Total Number Of Sites
- 55
- Total Number Of Participants
- 433
Spain
- Earliest CTIS Part Ii Submission Date
- 06-11-2024
- Latest Decision Or Authorization Date
- 23-05-2025
- Processing Time Days
- 198
- Number Of Sites
- 7
- Number Of Participants
- 433
Sites
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Cardiology
- Principal Investigator Name
- Alberto Alperi Garcia
- Principal Investigator Email
- alberto.alperi.garcia@hotmail.com
- Contact Person Name
- Alberto Alperi Garcia
- Contact Person Email
- alberto.alperi.garcia@hotmail.com
- Site Name
- Bellvitge University Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Angel Cequier
- Principal Investigator Email
- acequier@bellvitgehospital.cat
- Contact Person Name
- Angel Cequier
- Contact Person Email
- acequier@bellvitgehospital.cat
- Site Name
- Hospital General Universitario De Alicante
- Department Name
- Cardiology
- Principal Investigator Name
- Juan Miguel Ruiz Nodar
- Principal Investigator Email
- Ruiz_jmi@gva.es
- Contact Person Name
- Juan Miguel Ruiz Nodar
- Contact Person Email
- Ruiz_jmi@gva.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Cardiology
- Principal Investigator Name
- Natalia Royuela Martinez
- Principal Investigator Email
- natalia.royuela@scsalud.es
- Contact Person Name
- Natalia Royuela Martinez
- Contact Person Email
- natalia.royuela@scsalud.es
- Site Name
- Hospital San Pedro
- Department Name
- Cardiology
- Principal Investigator Name
- Luis Javier Alonso Perez
- Principal Investigator Email
- lalonso@riojasalud.es
- Contact Person Name
- Luis Javier Alonso Perez
- Contact Person Email
- lalonso@riojasalud.es
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- Cardiology
- Principal Investigator Name
- Victor Alfonso Jimenez Diaz
- Principal Investigator Email
- victor.alfonso.jimenez.diaz@sergas.es
- Contact Person Name
- Victor Alfonso Jimenez Diaz
- Contact Person Email
- victor.alfonso.jimenez.diaz@sergas.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Cardiology
- Principal Investigator Name
- Xavier Garcia-Moll Marimon
- Principal Investigator Email
- xgarcia-moll@santpau.cat
- Contact Person Name
- Xavier Garcia-Moll Marimon
- Contact Person Email
- xgarcia-moll@santpau.cat
Poland
- Earliest CTIS Part Ii Submission Date
- 06-11-2024
- Latest Decision Or Authorization Date
- 19-05-2025
- Processing Time Days
- 194
- Number Of Sites
- 9
- Number Of Participants
- 433
Sites
- Site Name
- Krakowski Szpital Specjalistyczny IM. Jana Pawla II
- Department Name
- Cardiology
- Principal Investigator Name
- Jacek Legutko
- Principal Investigator Email
- jacek.legutko@uj.edu.pl
- Contact Person Name
- Jacek Legutko
- Contact Person Email
- jacek.legutko@uj.edu.pl
- Site Name
- Slaskie Centrum Chorob Serca W Zabrzu
- Department Name
- Cardiology
- Principal Investigator Name
- Zbiniew Kalarus
- Principal Investigator Email
- Sek.KD1@sccs.pl
- Contact Person Name
- Zbiniew Kalarus
- Contact Person Email
- Sek.KD1@sccs.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Cardiology
- Principal Investigator Name
- Maciej Lesiak
- Principal Investigator Email
- maciej.lesiak@skpp.edu.pl
- Contact Person Name
- Maciej Lesiak
- Contact Person Email
- maciej.lesiak@skpp.edu.pl
- Site Name
- Szpital Uniwersytecki W Krakowie
- Department Name
- Cardiology
- Principal Investigator Name
- Stanislaw Bartus
- Principal Investigator Email
- mbbartus@cyfronet.pl
- Contact Person Name
- Stanislaw Bartus
- Contact Person Email
- mbbartus@cyfronet.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- Cardiology
- Principal Investigator Name
- Marcin Grabowski
- Principal Investigator Email
- marcin.grabowski@wum.edu.pl
- Contact Person Name
- Marcin Grabowski
- Contact Person Email
- marcin.grabowski@wum.edu.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Opolu
- Department Name
- Cardiology
- Principal Investigator Name
- Marek Gierlotka
- Principal Investigator Email
- marek.gierlotka@usk.opole.pl
- Contact Person Name
- Marek Gierlotka
- Contact Person Email
- marek.gierlotka@usk.opole.pl
- Site Name
- Wojewódzki Szpital Specjalistyczny we Wrocławiu Ośrodek Badawczo-Rozwojowy
- Department Name
- Cardiology
- Principal Investigator Name
- Tomasz Roleder
- Principal Investigator Email
- tomaszroleder@gmail.com
- Contact Person Name
- Tomasz Roleder
- Contact Person Email
- tomaszroleder@gmail.com
- Site Name
- Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy
- Department Name
- Cardiology
- Principal Investigator Name
- Jacek Kubica
- Principal Investigator Email
- jkubica@cm.umk.pl
- Contact Person Name
- Jacek Kubica
- Contact Person Email
- jkubica@cm.umk.pl
- Site Name
- Uniwersytecki Szpital Kliniczny (other Polish site)
- Department Name
- Cardiology
Germany
- Earliest CTIS Part Ii Submission Date
- 06-11-2024
- Latest Decision Or Authorization Date
- 05-06-2025
- Processing Time Days
- 211
- Number Of Sites
- 4
- Number Of Participants
- 433
Sites
- Site Name
- Otto Von Guericke Universitaet Magdeburg
- Department Name
- Cardiology, Angiology
- Principal Investigator Name
- Rüdiger Braun-Dullaeus
- Principal Investigator Email
- r.braun-dullaeus@med.ovgu.de
- Contact Person Name
- Rüdiger Braun-Dullaeus
- Contact Person Email
- r.braun-dullaeus@med.ovgu.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Medical Clinic II
- Principal Investigator Name
- Ingo Eitel
- Principal Investigator Email
- ingo.eitel@uksh.de
- Contact Person Name
- Ingo Eitel
- Contact Person Email
- ingo.eitel@uksh.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Interne Medizin I
- Principal Investigator Name
- Oliver Weingärtner
- Principal Investigator Email
- oliver.weingartner@med.uni-jena.de
- Contact Person Name
- Oliver Weingärtner
- Contact Person Email
- oliver.weingartner@med.uni-jena.de
- Site Name
- Herzzentrum Leipzig GmbH
- Department Name
- Internal Medicine/Cardiology
- Principal Investigator Name
- Holger Thiele
- Principal Investigator Email
- holger.thiele@medizin.uni-leipzig.de
- Contact Person Name
- Holger Thiele
- Contact Person Email
- holger.thiele@medizin.uni-leipzig.de
France
- Earliest CTIS Part Ii Submission Date
- 06-11-2024
- Latest Decision Or Authorization Date
- 18-11-2025
- Processing Time Days
- 377
- Number Of Sites
- 27
- Number Of Participants
- 434
Sites
- Site Name
- Centre Hospitalier Yves Le Foll
- Department Name
- Service de Cardiologie
- Principal Investigator Name
- Laurent PAYOT
- Principal Investigator Email
- laurent.payot@ch-stbrieuc.fr
- Contact Person Name
- Laurent PAYOT
- Contact Person Email
- laurent.payot@ch-stbrieuc.fr
- Site Name
- Centre Hospitalier De Versailles
- Department Name
- Service de cardiologie
- Principal Investigator Name
- Guillaume GODEAU
- Principal Investigator Email
- ggodeau@ch-versailles.fr
- Contact Person Name
- Guillaume GODEAU
- Contact Person Email
- ggodeau@ch-versailles.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Service de cardiologie
- Principal Investigator Name
- Fabrice PRUNIER
- Principal Investigator Email
- FaPrunier@chu-angers.fr
- Contact Person Name
- Fabrice PRUNIER
- Contact Person Email
- FaPrunier@chu-angers.fr
- Site Name
- Clinique Du Pont De Chaume
- Department Name
- Service de cardiologie
- Principal Investigator Name
- Thibaut PETRONI
- Principal Investigator Email
- petroni.cardio@gmail.com
- Contact Person Name
- Thibaut PETRONI
- Contact Person Email
- petroni.cardio@gmail.com
- Site Name
- Centre Hospitalier Metropole Savoie
- Department Name
- Service de Cardiologie
- Principal Investigator Name
- Laure BATIAS-MOREAU
- Principal Investigator Email
- Laure.Batias@ch-metropole-savoie.fr
- Contact Person Name
- Laure BATIAS-MOREAU
- Contact Person Email
- Laure.Batias@ch-metropole-savoie.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Service de Cardiologie
- Principal Investigator Name
- Guillaume CAYLA
- Principal Investigator Email
- guillaumecayla@free.fr
- Contact Person Name
- Guillaume CAYLA
- Contact Person Email
- guillaumecayla@free.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Service de cardiologie
- Principal Investigator Name
- Claire BOULETI
- Principal Investigator Email
- claire.bouleti@chu-poitiers.fr
- Contact Person Name
- Claire BOULETI
- Contact Person Email
- claire.bouleti@chu-poitiers.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de cardiologie
- Principal Investigator Name
- Jean-Guillaume DILLINGER
- Principal Investigator Email
- jean-guillaume.dillinger@aphp.fr
- Contact Person Name
- Jean-Guillaume DILLINGER
- Contact Person Email
- jean-guillaume.dillinger@aphp.fr
- Site Name
- Centre Hospitalier De Pau
- Department Name
- Service de cardiologie
- Principal Investigator Name
- Pierre POUSTIS
- Principal Investigator Email
- pierre.poustis@ch-pau.fr
- Contact Person Name
- Pierre POUSTIS
- Contact Person Email
- pierre.poustis@ch-pau.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Institut de Cardiologie)
- Department Name
- Institut de Cardiologie
- Principal Investigator Name
- Gilles MONTALESCOT
- Principal Investigator Email
- gilles.montalescot@aphp.fr
- Contact Person Name
- Gilles MONTALESCOT
- Contact Person Email
- gilles.montalescot@aphp.fr
- Site Name
- CHRU De Nancy
- Department Name
- Service de cardiologie
- Principal Investigator Name
- Batric POPOVIC
- Principal Investigator Email
- b.popovic@chru-nancy.fr
- Contact Person Name
- Batric POPOVIC
- Contact Person Email
- b.popovic@chru-nancy.fr
- Site Name
- Hopital NOVO
- Department Name
- Service cardiologie
- Principal Investigator Name
- Véronique DECALF
- Principal Investigator Email
- veronique.decalf@ght-novo.fr
- Contact Person Name
- Véronique DECALF
- Contact Person Email
- veronique.decalf@ght-novo.fr
- Site Name
- Centre Hospitalier D'Antibes Juan Les Pins
- Department Name
- Service de Cardiologie, USIC
- Principal Investigator Name
- Anne BELLEMAIN-APPAIX
- Principal Investigator Email
- anne.bellemain-appaix@ch-antibes.fr
- Contact Person Name
- Anne BELLEMAIN-APPAIX
- Contact Person Email
- anne.bellemain-appaix@ch-antibes.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Service de cardiologie Interventionnelle
- Principal Investigator Name
- Patrick OHLMANN
- Principal Investigator Email
- patrick.Ohlmann@chru-strasbourg.fr
- Contact Person Name
- Patrick OHLMANN
- Contact Person Email
- patrick.Ohlmann@chru-strasbourg.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- DépartemCardiologie et Maladies Vasculaires
- Principal Investigator Name
- Géraud SOUTEYRAND
- Principal Investigator Email
- gsouteyrand@chu-clermontferrand.fr
- Contact Person Name
- Géraud SOUTEYRAND
- Contact Person Email
- gsouteyrand@chu-clermontferrand.fr
- Site Name
- CHU Besancon
- Department Name
- Service de cardiologie - Pôle Cœur-Poumons
- Principal Investigator Name
- François SCHIELE
- Principal Investigator Email
- francois.schiele@univ-fcomte.fr
- Contact Person Name
- François SCHIELE
- Contact Person Email
- francois.schiele@univ-fcomte.fr
- Site Name
- Centre Hospitalier De Haguenau
- Department Name
- Service de cardiologie interventionnelle et USIC
- Principal Investigator Name
- Sabrina UHRY
- Principal Investigator Email
- sabrina.uhry@ch-haguenau.fr
- Contact Person Name
- Sabrina UHRY
- Contact Person Email
- sabrina.uhry@ch-haguenau.fr
- Site Name
- Centre Hospitalier De Colmar
- Department Name
- Service de Cardiologie
- Principal Investigator Name
- Laszlo LEVAI
- Principal Investigator Email
- doclevai@calixo.net
- Contact Person Name
- Laszlo LEVAI
- Contact Person Email
- doclevai@calixo.net
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Service de Cardiologie
- Principal Investigator Name
- Emilie FERRARI
- Principal Investigator Email
- ferrari.e@chu-nice.fr
- Contact Person Name
- Emilie FERRARI
- Contact Person Email
- ferrari.e@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service de Cardiologie
- Principal Investigator Name
- Meyer ELBAZ
- Principal Investigator Email
- elbaz.m@chu-toulouse.fr
- Contact Person Name
- Meyer ELBAZ
- Contact Person Email
- elbaz.m@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Cardio Vasculaire et Pulmonaire
- Principal Investigator Name
- Eric VAN BELLE
- Principal Investigator Email
- e-vanbelle@chru-lille.fr
- Contact Person Name
- Eric VAN BELLE
- Contact Person Email
- e-vanbelle@chru-lille.fr
- Site Name
- Les Hopitaux De Chartres
- Department Name
- Service de Cardiologie
- Principal Investigator Name
- Gregoire RANGE
- Principal Investigator Email
- grange@ch-chartres.f
- Contact Person Name
- Gregoire RANGE
- Contact Person Email
- grange@ch-chartres.f
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- Service de Cardiologie
- Principal Investigator Name
- Jacques CHANPENG
- Principal Investigator Email
- jacques.chan-peng@ght85.fr
- Contact Person Name
- Jacques CHANPENG
- Contact Person Email
- jacques.chan-peng@ght85.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Institut du thorax
- Principal Investigator Name
- Julien PLESSIS
- Principal Investigator Email
- Julien.PLESSIS@chu-nantes.fr
- Contact Person Name
- Julien PLESSIS
- Contact Person Email
- Julien.PLESSIS@chu-nantes.fr
- Site Name
- Centre Hospitalier De La Cote Basque
- Department Name
- Service de cardiologie
- Principal Investigator Name
- Jean Noel LABEQUE
- Principal Investigator Email
- dr.jnlabeque@gmail.com
- Contact Person Name
- Jean Noel LABEQUE
- Contact Person Email
- dr.jnlabeque@gmail.com
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Soins Intensifs et Cardiologie Interventionnelle
- Principal Investigator Name
- Denis ANGOULVANT
- Principal Investigator Email
- d.angoulvant@chu-tours.fr
- Contact Person Name
- Denis ANGOULVANT
- Contact Person Email
- d.angoulvant@chu-tours.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Service de Cardiologie et Pathologie Vasculaire
- Principal Investigator Name
- Farzin BEYGUI
- Principal Investigator Email
- beygui-f@chu-caen.fr
- Contact Person Name
- Farzin BEYGUI
- Contact Person Email
- beygui-f@chu-caen.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 06-11-2024
- Latest Decision Or Authorization Date
- 05-12-2025
- Processing Time Days
- 394
- Number Of Sites
- 8
- Number Of Participants
- 433
Sites
- Site Name
- Sant'Andrea Hospital, La Spezia, ASL5 Liguria
- Department Name
- Cardiology
- Principal Investigator Name
- Alberto Menozzi
- Principal Investigator Email
- albemenozzi@gmail.com
- Contact Person Name
- Alberto Menozzi
- Contact Person Email
- albemenozzi@gmail.com
- Site Name
- Azienda Ospedaliero-Universitaria Sant'Anna
- Department Name
- Cardiology
- Principal Investigator Name
- Gianluca Campo
- Principal Investigator Email
- cmpglc@unife.it
- Contact Person Name
- Gianluca Campo
- Contact Person Email
- cmpglc@unife.it
- Site Name
- Azienda Sanitaria Locale Di Pescara
- Department Name
- Cardiology
- Principal Investigator Name
- Leonardo Paloscia
- Principal Investigator Email
- leonardo.paloscia@ausl.pe.it
- Contact Person Name
- Leonardo Paloscia
- Contact Person Email
- leonardo.paloscia@ausl.pe.it
- Site Name
- Azienda Unita' Sanitaria Locale Toscana Sud Est
- Department Name
- Cardiology
- Principal Investigator Name
- Andrea Picchi
- Principal Investigator Email
- andra.picchi@uslsudest.toscana.it
- Contact Person Name
- Andrea Picchi
- Contact Person Email
- andra.picchi@uslsudest.toscana.it
- Site Name
- Federico II University of Naples
- Department Name
- Cardiology
- Principal Investigator Name
- Giovanni Esposito
- Principal Investigator Email
- giovanni.esposito2@unina.it
- Contact Person Name
- Giovanni Esposito
- Contact Person Email
- giovanni.esposito2@unina.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- Cardiology
- Principal Investigator Name
- Giuseppe Patti
- Principal Investigator Email
- giuseppe.patti@uniupo.it
- Contact Person Name
- Giuseppe Patti
- Contact Person Email
- giuseppe.patti@uniupo.it
- Site Name
- Azienda Sanitaria Locale TO3
- Department Name
- Cardiology
- Principal Investigator Name
- Giulio Piedimonte
- Principal Investigator Email
- giulio.piedimonte@gmail.com
- Contact Person Name
- Giulio Piedimonte
- Contact Person Email
- giulio.piedimonte@gmail.com
- Site Name
- Ospedale San Donato
- Department Name
- Cardiology
- Principal Investigator Name
- Maurizio Chioccioli
- Principal Investigator Email
- maurizio.chioccioli@uslsudest.toscana.it
- Contact Person Name
- Maurizio Chioccioli
- Contact Person Email
- maurizio.chioccioli@uslsudest.toscana.it
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Paris
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Third parties
- {"country":"","full_name":"AMGEN","duties_or_roles":"Source of monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- Repatha 140 mg solution for injection in pre-filled pen
- Active Substance
- Evolocumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- Authorised (marketing authorisation EU/1/15/1016/002)
- Maximum Dose
- Max daily dose 140 mg; max total dose 11060 mg
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