Chart Review of Repatha® in Subjects With Hyperlipidaemia

NCT ID: NCT02770131

Last Updated: 2024-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1986 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-04

Study Completion Date

2021-06-30

Brief Summary

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Review of clinical characteristics of patients who are prescribed Repatha® and how their treatment is managed.

Detailed Description

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Conditions

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Hypercholesterolaemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

To describe the clinical characteristics of subjects at initiation of Repatha® (up to 2000 subjects).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Adults (\>18 years) Provided informed consent Initiated on Repatha® at physician's discretion, after 1st August 2015 Received at least one dose of Repatha®

Exclusion Criteria

Enrolled in an interventional study of PCSK9 inhibitor within 12 weeks prior to initiation of Repatha® Received commercially available PCSK9 inhibitor within 12 weeks prior to initiation of Repatha®
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Feldkirch, , Austria

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Graz, , Austria

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Innsbruck, , Austria

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Klagenfurt, , Austria

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Linz, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Villach, , Austria

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Aalst, , Belgium

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Genk, , Belgium

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Ghent, , Belgium

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La Louvière, , Belgium

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Leuven, , Belgium

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Kostenets, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Varna, , Bulgaria

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Varna, , Bulgaria

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Brno, , Czechia

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České Budějovice, , Czechia

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Hradec Králové, , Czechia

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Liberec, , Czechia

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Olomouc, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Ústí nad Labem, , Czechia

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Zlín, , Czechia

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Aachen, , Germany

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Bad Reichenhall, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Bochum, , Germany

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Borsdorf, , Germany

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Detmold, , Germany

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Garbsen, , Germany

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Germering, , Germany

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Göttingen, , Germany

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Halberstadt, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Langenhagen, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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Mannheim, , Germany

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Markleeberg, , Germany

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Mönchengladbach, , Germany

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Mühldorf, , Germany

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Mülheim, , Germany

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München, , Germany

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München, , Germany

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Neuwied, , Germany

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Nuremberg, , Germany

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Oschatz, , Germany

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Pirna, , Germany

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Potsdam, , Germany

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Rostock, , Germany

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Rotenburg (Wümme), , Germany

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Viersen-Dülken, , Germany

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Villingen-Schwenningen, , Germany

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Zwickau, , Germany

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Alexandroupoli, , Greece

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Heraklion, , Greece

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Ioannina, , Greece

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Larissa, , Greece

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Piraeus, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Acerra, , Italy

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Arzignano, , Italy

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Asti, , Italy

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Bassano Del Grappa (VI), , Italy

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Bologna, , Italy

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Brescia, , Italy

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Brindisi, , Italy

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Catanzaro, , Italy

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Cinisello Balsamo (MI), , Italy

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Cona FE, , Italy

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Cosenza, , Italy

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Foggia, , Italy

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Lido Di Camaiore LU, , Italy

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Messina, , Italy

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Mestre (VE), , Italy

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Milan, , Italy

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Milan, , Italy

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Milan, , Italy

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Napoli, , Italy

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Padua, , Italy

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Palermo, , Italy

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Pescara, , Italy

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Reggio Calabria, , Italy

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Rivoli, , Italy

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Roma, , Italy

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Roma, , Italy

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Salerno, , Italy

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Seriate, , Italy

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Sesto San Giovanni (MI), , Italy

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Taranto, , Italy

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Torrette Di Ancona, , Italy

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Treviglio (BG), , Italy

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Trieste, , Italy

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Almada, , Portugal

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Carnaxide, , Portugal

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Coimbra, , Portugal

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Faro, , Portugal

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Matosinhos Municipality, , Portugal

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Porto, , Portugal

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Banská Bystrica, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Brezno, , Slovakia

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Handlová, , Slovakia

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Komárno, , Slovakia

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Košice, , Slovakia

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Košice, , Slovakia

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Martin, , Slovakia

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Martin, , Slovakia

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Moldava nad Bodvou, , Slovakia

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Myjava, , Slovakia

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Námestovo, , Slovakia

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Nitra, , Slovakia

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Nitra, , Slovakia

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Nitra, , Slovakia

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Nové Mesto nad Váhom, , Slovakia

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Nové Zámky, , Slovakia

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Poprad, , Slovakia

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Prešov, , Slovakia

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Rožňava, , Slovakia

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Trnava, , Slovakia

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Žilina, , Slovakia

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Cadiz, Andalusia, Spain

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Huelva, Andalusia, Spain

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Jaén, Andalusia, Spain

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Málaga, Andalusia, Spain

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Seville, Andalusia, Spain

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Seville, Andalusia, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Badalona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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Reus, Catalonia, Spain

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Sabadell, Catalonia, Spain

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Ferrol, Galicia, Spain

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Lugo, Galicia, Spain

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Alcalá de Henares, Madrid, Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Gothenburg, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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Uppsala, , Sweden

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Basel, , Switzerland

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Geneva, , Switzerland

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Lugano, , Switzerland

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Winterthur, , Switzerland

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Zurich, , Switzerland

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Zurich, , Switzerland

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Countries

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Austria Belgium Bulgaria Czechia Germany Greece Italy Portugal Slovakia Spain Sweden Switzerland

References

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Ray KK, Dhalwani N, Sibartie M, Bridges I, Ebenbichler C, Perrone-Filardi P, Villa G, Vogt A, Bruckert E. Low-density lipoprotein cholesterol levels exceed the recommended European threshold for PCSK9i initiation: lessons from the HEYMANS study. Eur Heart J Qual Care Clin Outcomes. 2022 Jun 6;8(4):447-460. doi: 10.1093/ehjqcco/qcac009.

Reference Type BACKGROUND
PMID: 35175350 (View on PubMed)

Blaha V, Margoczy R, Petrov I, Postadzhiyan A, Raslova K, Rosolova H, Bridges I, Dhalwani NN, Zachlederova M, Ray KK. Evolocumab is Initiated in Central and Eastern Europe at Much Higher LDL-C Levels Than Recommended in Guidelines: Results from the Observational HEYMANS Study. J Cardiovasc Pharmacol Ther. 2023 Jan-Dec;28:10742484231172847. doi: 10.1177/10742484231172847.

Reference Type BACKGROUND
PMID: 37218974 (View on PubMed)

Blanco Echevarria A, Garcia Diaz JD, Caixas A, Plana Gil N, Rico Corral MA, Bridges I, Dhalwani N, Gatell Menchen S, Ray KK. Long-term treatment persistence and maintained reduction of LDL-cholesterol levels with evolocumab over 30 months: Results from the Spanish cohort of the European prospective HEYMANS study. Clin Investig Arterioscler. 2023 Nov-Dec;35(6):263-271. doi: 10.1016/j.arteri.2023.04.004. Epub 2023 May 24. English, Spanish.

Reference Type BACKGROUND
PMID: 37236829 (View on PubMed)

Ebenbichler C, Drexel H, Hanusch U, Toplak H, Dhalwani NN, Bridges I, Hoelzl R, Hemetsberger M, Ray KK. Evolocumab effectiveness in the real-world setting: Austrian data from the pan-European observational HEYMANS study. Wien Klin Wochenschr. 2024 Feb;136(3-4):77-86. doi: 10.1007/s00508-023-02245-w. Epub 2023 Jul 31.

Reference Type BACKGROUND
PMID: 37525072 (View on PubMed)

Sudano I, Krahenbuhl S, Mach F, Anstett A, Dhalwani N, Bridges I, Sibartie M, Ray KK. Evolocumab use in clinical practice in Switzerland: final data of the observational HEYMANS cohort study. Ther Adv Cardiovasc Dis. 2024 Jan-Dec;18:17539447231213288. doi: 10.1177/17539447231213288.

Reference Type BACKGROUND
PMID: 38183273 (View on PubMed)

Lehrke M, Vogt A, Schettler V, Girndt M, Fraass U, Tabbert-Zitzler A, Bridges I, Dhalwani NN, Ray KK. Evolocumab-Based LDL-C Management in High and Very High Cardiovascular Risk Patients in German Clinical Practice: The HEYMANS Study. Adv Ther. 2024 Mar;41(3):1184-1200. doi: 10.1007/s12325-023-02757-x. Epub 2024 Jan 30.

Reference Type BACKGROUND
PMID: 38286961 (View on PubMed)

Vlachopoulos C, Massia D, Kochiadakis G, Kolovou G, Patsilinakos S, Bridges I, Sibartie M, Dhalwani NN, Liberopoulos E, Ray KK. Evolocumab use in Greece is associated with early and sustainable reductions in low-density cholesterol (LDL-C) and high persistence to therapy: Results from the Greek cohort analysis of the observational HEYMANS study. Hellenic J Cardiol. 2023 Nov-Dec;74:74-76. doi: 10.1016/j.hjc.2023.09.003. Epub 2023 Sep 18. No abstract available.

Reference Type BACKGROUND
PMID: 37730147 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20130296

Identifier Type: -

Identifier Source: org_study_id

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