Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
- Registration Number
- NCT03080935
- Lead Sponsor
- Amgen
- Brief Summary
This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). Approximately 1600 subjects will be enrolled in this study. This study will continue for 260 weeks (approximately 5 years).
- Detailed Description
This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). FOURIER is a randomized placebo-controlled study of evolocumab, in patients with clinically evident atherosclerotic CVD on stable effective statin therapy. Subjects at sites participating in FOURIER OLE (Study 20160250) who are eligible and have signed the FOURIER OLE informed consent will be enrolled after completion of FOURIER.
The FOURIER OLE study requires laboratory assessments at day 1, week 12, and thereafter approximately every 6 months from day 1; the corresponding blood samples will be processed using a central laboratory.
Upon enrollment in FOURIER OLE study, subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) according to their preference. Frequency and corresponding dose of administration can be changed at any scheduled time point where evolocumab is supplied to the subject, provided the appropriate supply is available. It is recommended that subjects continue the same background lipid-lowering therapy (LLT), including statin, as taken during FOURIER.
This study will continue for 260 weeks (approximately 5 years). Subjects ending administration of evolocumab should continue study assessments until the end of study. All subjects will be followed and complete procedures/assessments from enrollment through the date of study termination unless the subject has withdrawn consent, irrespective of whether the subject is continuing to receive treatment.
All deaths and cardiovascular events of interest will be reviewed by an independent external Clinical Events Committee (CEC), using standardized definitions.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1600
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- Subject had completed FOURIER (Study 20110118) while still receiving assigned Investigational Product.
- Permanent discontinuation of Investigational Product during FOURIER for any reason including an adverse event or serious adverse event.
- Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
- History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Subject has known sensitivity to any of the active substances or excipients (eg, sodium acetate) to be administered during dosing.
- Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment with evolocumab and for an additional 15 weeks after treatment with evolocumab discontinues.
- Female subjects of childbearing potential unwilling to use an acceptable method of effective contraception during treatment and for an additional 15 weeks after the last dose of protocol-required therapies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Evolocumab Evolocumab Single arm study administering Evolocumab.
- Primary Outcome Measures
Name Time Method Number of Participants Who Experienced an Adverse Event Up to 5 years All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260 Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Trial Locations
- Locations (85)
Centre Hospitalier Universitaire Brugmann
🇧🇪Brussels, Belgium
Algemeen Ziekenhuis Sint Lucas
🇧🇪Gent, Belgium
Imelda Ziekenhuis vzw
🇧🇪Bonheiden, Belgium
Centres Hospitaliers Jolimont - Hopital de Jolimont
🇧🇪La Louvière, Belgium
Centro Hospitalar de Setubal EPE Hospital de Sao Bernardo
🇵🇹Setubal, Portugal
Onze Lieve Vrouw Ziekenhuis Aalst
🇧🇪Aalst, Belgium
Ziekenhuis Netwerk Antwerpen Middelheim
🇧🇪Antwerpen, Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
🇧🇪Antwerpen, Belgium
Centro Hospitalar Cova da Beira, EPE - Hospital Pero da Covilha
🇵🇹Covilha, Portugal
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
🇮🇹Siena, Italy
Aarhus Universitetshospital
🇩🇰Aarhus N, Denmark
Sydvestjysk Sygehus
🇩🇰Esbjerg, Denmark
Algemeen Stedelijk Ziekenhuis Aalst
🇧🇪Aalst, Belgium
Cliniques universitaires de Bruxelles Hopital Erasme
🇧🇪Brussels, Belgium
Medif sprl
🇧🇪Gozee, Belgium
Aalborg Hospital
🇩🇰Aalborg, Denmark
Center for Clinical and Basic Research Aalborg
🇩🇰Aalborg, Denmark
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
🇧🇪Bruxelles, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Centre Hospitalier Universitaire de Tivoli
🇧🇪La Louvière, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
🇧🇪Liege, Belgium
Centre Hospitalier Regional de la Citadelle
🇧🇪Liège, Belgium
Algemeen Ziekenhuis Turnhout
🇧🇪Turnhout, Belgium
Amager Hospital
🇩🇰Kobenhavn S, Denmark
Odense Universitetssygehus
🇩🇰Odense, Denmark
Centro Hospitalar e Universitario de Coimbra EPE
🇵🇹Coimbra, Portugal
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier
🇵🇹Lisboa, Portugal
Nouvelles Cliniques Nantaises
🇫🇷Nantes Cedex 2, France
Länssjukhuset Ryhov
🇸🇪Jönköping, Sweden
Hospital Cuf Infante Santo
🇵🇹Lisboa, Portugal
Centre Hospitalier Regional Universitaire de Montpellier - Hopital Arnaud de Villeneuve
🇫🇷Montpellier cedex 05, France
Centre Hospitalier de Pau - Hopital Francois Mitterrand
🇫🇷Pau, France
Helios Universitätsklinikum Wuppertal
🇩🇪Wuppertal, Germany
Vivantes Klinikum Neukölln
🇩🇪Berlin, Germany
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
🇫🇷Toulouse Cedex 9, France
Forschungszentrum Ruhr
🇩🇪Witten, Germany
Hospital Garcia de Orta, EPE
🇵🇹Almada, Portugal
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Johannes Gutenberg Universität Mainz
🇩🇪Mainz, Germany
Falu Lasarett
🇸🇪Falun, Sweden
Capio Citykliniken
🇸🇪Lund, Sweden
Centro Cardiologico Monzino
🇮🇹Milano, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Azienda Ospedaliero Universitaria Careggi
🇮🇹Firenze, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
🇮🇹Palermo, Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
🇮🇹Perugia, Italy
Centre for Clinical and Basic Research Ballerup
🇩🇰Ballerup, Denmark
Frederiksberg/Bispebjerg Hospitaler
🇩🇰Frederiksberg, Denmark
Glostrup Hospital
🇩🇰Glostrup, Denmark
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Sjaellands Universitetshospital, Roskilde
🇩🇰Roskilde, Denmark
Svendborg Sygehus
🇩🇰Svendborg, Denmark
Center for Clinical and Basic Research Vejle
🇩🇰Vejle, Denmark
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
🇫🇷Nice, France
Regionshospitalet Viborg
🇩🇰Viborg, Denmark
Centre Hospitalier Régional Universitaire de Tours - Hôpital Trousseau
🇫🇷Chambray les Tours, France
Hopital Louis Pasteur
🇫🇷Le Coudray, France
Centre Hospitalier Universitaire de Nantes - Hopital Guillaume et Rene Laennec
🇫🇷Nantes Cedex 1, France
Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz
🇫🇷Besancon cedex, France
Hopital Lariboisiere
🇫🇷Paris, France
Hopital Pitie-Salpetriere
🇫🇷Paris, France
Centre Hospitalier Universitaire de Reims - Hopital Robert Debre
🇫🇷Reims, France
Centre Hospitalier Intercommunal Haute Saone
🇫🇷Vesoul, France
Universitaets-Herzzentrum Freiburg - Bad Krozingen
🇩🇪Bad Krozingen, Germany
Klinische Forschung Berlin GbR
🇩🇪Berlin, Germany
Sankt-Johannes-Hospital
🇩🇪Dortmund, Germany
Deutsches Rotes Kreuz Kliniken Berlin Köpenick
🇩🇪Berlin, Germany
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
Ambulantes Herzzentrum Kassel
🇩🇪Kassel, Germany
Gesellschaft fur Wissens und Technologietransfer der Technischen Uni Dresden
🇩🇪Dresden, Germany
Otto von Guericke Universität Magdeburg
🇩🇪Magdeburg, Germany
Universitätsklinikum Köln
🇩🇪Köln, Germany
Herz-Gefäß-Zentrum Nymphenburg am Klinikum Dritter Orden
🇩🇪München, Germany
Robert Bosch Krankenhaus
🇩🇪Stuttgart, Germany
Deutsches Herzzentrum München des Freistaates Bayern
🇩🇪München, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Fondazione Toscana Gabriele Monasterio, Stabilimento Ospedaliero di Pisa
🇮🇹Pisa, Italy
Skanes Universitetssjukhus
🇸🇪Lund, Sweden
Sunderby Sjukhus
🇸🇪Lulea, Sweden
Helsingborgs Lasarett
🇸🇪Helsingborg, Sweden
Akardo MedSite
🇸🇪Stockholm, Sweden
Universitetssjukhuset Ã-rebro
🇸🇪Orebro, Sweden
Ostersunds sjukhus
🇸🇪Ostersund, Sweden
Norrlands Universitetssjukhus
🇸🇪Umea, Sweden