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NCT05643573CompletedPhase 3

A study to learn how well the study treatment asundexian works and how safe it is compared to apixaban to prevent stroke or systemic embolism in people with irregular and often rapid heartbeat (atrial fibrillation), and at risk for stroke

(19767 OCEANIC-AF) A multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke

Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Oct 2023

Brief summary (registry, in English)

To demonstrate that asundexian is superior (at least non-inferior) when compared with apixaban for prevention of stroke and systemic embolism in participants with atrial fibrillation at risk for stroke. To demonstrate that asundexian is superior to apixaban as assessed by International Society on Thrombosis and Hemostasis (ISTH) major bleeding in participants with atrial fibrillation at risk for stroke. To demonstrate that asundexian is superior to apixaban with respect to benefit and risk.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
9578 (actual)
First submitted
4 Aug 2023
Start date
24 Nov 2022
Lead sponsor
Bayer AG
NCT number
NCT05643573
EU CT number
2023-503794-38-00
EudraCT number
2022-000758-28

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 9578
  • 436 sites in 22 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Mechanical heart valve prosthesis

Other

  • Moderate-to-severe mitral stenosis at the time of inclusion into the study
  • Atrial fibrillation only due to reversible cause
  • Requirement for chronic anticoagulation for a different indication than atrial fibrillation

Who the study is looking for

  • 18 years of age or older (at legal age of consent according to local legislation) at the time of signing the informed consent
  • Atrial fibrillation documented by ECG evidence with an indication for indefinite treatment with an oral anticoagulant
  • CHA2DS2-VASc score >=3 if male or >= 4 if female, OR CHA2DS2-VASc score of 2 if male or 3 if female and enrichment criteria.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (436)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
A.O. Krankenhaus St. Josef Braunau GmbH
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Braunau Am InnAustriaCompleted
Vivit Institute
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FeldkirchAustriaCompleted
Medical University of Graz
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GrazAustriaCompleted
A.ö. Landeskrankenhaus Hall
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Hall in TirolAustriaCompleted
Medizinische Universitaet Innsbruck
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InnsbruckAustriaCompleted
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
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Klagenfurt Am WoertherseeAustriaCompleted
Kepler Universitaetsklinikum GmbH
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LinzAustriaCompleted
Ordensklinikum Linz GmbH
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LinzAustriaCompleted
NOE Landesgesundheitsagentur
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MistelbachAustriaCompleted
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
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SalzburgAustriaCompleted
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaCompleted
Imed19 Betriebs GmbH
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ViennaAustriaCompleted
Krankenhaus Nord - Klinik Floridsdorf
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ViennaAustriaCompleted
Hanusch Krankenhaus der Wiener Gebietskrankenkasse
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ViennaAustriaCompleted
Medical University of Vienna
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ViennaAustriaCompleted
Klinikum Wels-Grieskirchen GmbH
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WelsAustriaCompleted
Algemeen Stedelijk Ziekenhuis - campus Aalst
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AalstBelgiumCompleted
Onze-Lieve-Vrouwziekenhuis
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AalstBelgiumCompleted
Het Ziekenhuisnetwerk Antwerpen
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AntwerpBelgiumCompleted
A Z Monica
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AntwerpBelgiumCompleted
GasthuisZusters Antwerpen
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AntwerpBelgiumCompleted
Imelda
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BonheidenBelgiumCompleted
Algemeen Ziekenhuis klina
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BrasschaatBelgiumCompleted
Az St-Jan Brugge-Oostende A.V.
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BruggeBelgiumCompleted
Grand Hopital de Charleroi
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CharleroiBelgiumCompleted
O.L.Vrouw van Troost
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DendermondeBelgiumCompleted
Antwerp University Hospital
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EdegemBelgiumCompleted
Ziekenhuis Oost-Limburg
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GenkBelgiumCompleted
Az Maria Middelares Gent
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GentBelgiumCompleted
AZ Sint-Lucas & Volkskliniek
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GentBelgiumCompleted
JESSA Ziekenhuis
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HasseltBelgiumCompleted
Algemeen Ziekenhuis Groeninge
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KortrijkBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
CHC MontLégia
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LiègeBelgiumCompleted
Centre Hospitalier Regional de la Citadelle
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LiègeBelgiumCompleted
A.Z. Sint-Maarten
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MechelenBelgiumCompleted
AZ Delta
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RoeselareBelgiumCompleted
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumCompleted
Vitaz
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Sint-NiklaasBelgiumCompleted
Chu Ucl Namur
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YvoirBelgiumCompleted
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
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BlagoevgradBulgariaCompleted
Multi-profile Hospital for Active Treatment Heart and Brain EAD
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BurgasBulgariaCompleted
Meditsinski Tsentar Avitsena EOOD
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KirdzhaliBulgariaCompleted
Multidisciplinary Hospital For Active Treatment Saint George Pernik Ltd.
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PernikBulgariaCompleted
MBAL Med Line Clinic AD
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PlovdivBulgariaCompleted
MBAL Sveta Karidad EAD
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PlovdivBulgariaCompleted
Medicinski Centar Hipokrat-N EOOD
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PlovdivBulgariaCompleted
Medical Center Rusemed EOOD
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RuseBulgariaCompleted
Multiprofile Hospital For Active Treatment - Shumen AD
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ShumenBulgariaCompleted
Multiprofile Hospital for Active Treatment - Silistra AD
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SilistraBulgariaCompleted
Medical centre Kardiohelp EOOD
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SofiaBulgariaCompleted
Diagnostic Consultative Centre Ascendent OOD
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SofiaBulgariaCompleted
Diagnostic Consultation Center XX-Sofia EOOD
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SofiaBulgariaCompleted
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
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SofiyaBulgariaCompleted
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
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SofiyaBulgariaCompleted
Second Medical Center-Sofia
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SofiyaBulgariaCompleted
University Hospital Queen Govanna
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SofiyaBulgariaCompleted
Multiprofile Hospital for Active Treatment Sveta Sofia
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SofiyaBulgariaCompleted
MHAT National Heart Hospital EAD
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SofiyaBulgariaCompleted
MBAL Trakia EOOD
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Stara ZagoraBulgariaCompleted
Medical Center Zara-Med EOOD
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Stara ZagoraBulgariaCompleted
Medcenter Nova Clinic Ltd.
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VarnaBulgariaCompleted
Multiprofile Regional Hospital For Active Treatment Dr. Stefan Cherkezov AD
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Veliko TirnovoBulgariaCompleted
Fakultni nemocnice Brno
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BrnoCzechiaCompleted
Kardiologicka ambulance Brno s.r.o.
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Brno-Královo PoleCzechiaCompleted
Amkardia s.r.o.
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Brno-StredCzechiaCompleted
Vojenska Nemocnice Brno
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Brno-ZideniceCzechiaCompleted
CorMedico s.r.o.
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BruntalCzechiaCompleted
Nemocnice České Budějovice, a.s.
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České BudějoviceCzechiaCompleted
Mrozek Kardiologie s.r.o.
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FrydekCzechiaCompleted
CTC Hodonin s.r.o.
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HodonínCzechiaCompleted
Krajska nemocnice Liberec a.s.
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Liberec (neclenene Mesto)CzechiaCompleted
University Hospital Olomouc
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OlomoucCzechiaCompleted
MU Dr. Michalík Daniel
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OstravaCzechiaCompleted
Fakultni Nemocnice Plzen
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Plzen 23CzechiaCompleted
Institute for Clinical and Experimental Medicine
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PragueCzechiaCompleted
MEDICON a.s.
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PragueCzechiaCompleted
Fakultní Nemocnice Královské Vinohrady
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Prague 10CzechiaCompleted
Fakultni Nemocnice V Motole
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Prague 5CzechiaCompleted
Ordinace Dejvice s.r.o.
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Prague 6CzechiaCompleted
Benedor s.r.o.
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PustkovecCzechiaCompleted
Nemocnice Slany
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SlanýCzechiaCompleted
Cardio Research, s.r.o
Coordinator of this site? Confirm its status
ZlínCzechiaCompleted
Universitaetsklinikum Aachen AöR
Coordinator of this site? Confirm its status
AachenGermanyCompleted
Medical Center - University Of Freiburg
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Bad KrozingenGermanyCompleted
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
St. Vinzenz-Hospital GmbH
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CologneGermanyCompleted
Kath. St. Paulus GmbH
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DortmundGermanyCompleted
Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH
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DresdenGermanyCompleted
Klinische Forschung Dresden GmbH
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DresdenGermanyCompleted
Staedtisches Klinikum Dresden
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DresdenGermanyCompleted
Klinikum Frankfurt Hoechst GmbH
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Frankfurt Am MainGermanyCompleted
Evangelisches Krankenhaus Hagen-Haspe gGmbH
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HagenGermanyCompleted
Klinische Forschung Hamburg GmbH
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HamburgGermanyCompleted
Cardiologicum Hamburg GbR
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HamburgGermanyCompleted
University Medical Center Hamburg-Eppendorf
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HamburgGermanyCompleted
Medizinische Hochschule Hannover
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HanoverGermanyCompleted
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyCompleted
University Hospital Jena KöR
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JenaGermanyCompleted
MediClin Herzzentrum Lahr
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LahrGermanyCompleted
Universitaetsklinikum Leipzig Aor
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LeipzigGermanyCompleted
Cardio Centrum Ludwigsburg-Bietigheim
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LudwigsburgGermanyCompleted
Maerkische Kliniken GmbH
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LuedenscheidGermanyCompleted
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz Koerperschaft Des Offentlichen Rechts
Coordinator of this site? Confirm its status
MainzGermanyCompleted
Praxis für Innere Medizin und Kardiologie, Angiologie
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MarkkleebergGermanyCompleted
Kliniken Maria Hilf GmbH Moenchengladbach
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MoenchengladbachGermanyCompleted
Sana-Klinikum Remscheid GmbH
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RemscheidGermanyCompleted
Rostock University Medical Center
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RostockGermanyCompleted
Gesundheitsverbund Landkreis Konstanz gGmbH
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Singen (Hohentwiel)GermanyCompleted
Siteworks GmbH
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VoelklingenGermanyCompleted
Josephs-Hospital
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WarendorfGermanyCompleted
Kardiologische Praxis
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WermsdorfGermanyCompleted
KliFoCenter GmbH
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WittenGermanyCompleted
Klinikum Worms gGmbH
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WormsGermanyCompleted
Aalborg University Hospital
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AalborgDenmarkCompleted
Region Midtjylland
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Aarhus NDenmarkCompleted
Amager Hospital
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Copenhagen SDenmarkCompleted
Sydvestjysk Sygehus
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EsbjergDenmarkCompleted
Frederiksberg Hospital
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FrederiksbergDenmarkCompleted
Gentofte Hospital
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HellerupDenmarkCompleted
Herlev Hospital
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HerlevDenmarkCompleted
Region Midtjylland
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HerningDenmarkCompleted
Hillerod Hospital
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HilleroedDenmarkCompleted
Regionshospital Nordjylland
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HjoerringDenmarkCompleted
Region Sjaelland
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HolbækDenmarkCompleted
Hvidovre Hospital
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HvidovreDenmarkCompleted
Lillebaelt Hospital
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KoldingDenmarkCompleted
Zealand University Hospital
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RoskildeDenmarkCompleted
Odense University Hospital
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SvendborgDenmarkCompleted
Region Midtjylland
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ViborgDenmarkCompleted
Laane-Tallinna Keskhaigla AS
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Pohja-Tallinna LinnaosaEstoniaCompleted
Pirita Perearstikeskus OÜ
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TallinnEstoniaCompleted
Dr.Signe Alliksoo Perearstipraksis OÜ
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TallinnEstoniaCompleted
East Tallinn Central Hospital
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TallinnEstoniaCompleted
North Estonia Medical Centre Foundation
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TallinnEstoniaCompleted
Dr Arvo Rosenthal OÜ
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TallinnEstoniaCompleted
Tartu University Hospital
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Tartu LinnEstoniaCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital General Universitario Dr. Balmis
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AlicanteSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Hospital Quirónsalud Barcelona
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BarcelonaSpainCompleted
Area Sanitaria De Ferrol
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FerrolSpainCompleted
Hospital Alta Resolución de Lebrija
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Lebrija SevillaSpainCompleted
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainCompleted
Hospital Universitario de la Princesa
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainCompleted
Hospital Universitario Central De Asturias
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OviedoSpainCompleted
Hospital Virgen del Camino
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Sanlúcar de BarramedaSpainCompleted
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital Alta Resolución De Utrera
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Utrera AndaluciaSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
Hospital General Universitario de Valencia
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ValenciaSpainCompleted
Hospital Virgen de las Montañas
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VillamartínSpainCompleted
HUS Helsinki University Hospital
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EspooFinlandCompleted
HUS Helsinki University Hospital
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HelsinkiFinlandCompleted
Studycor Oy
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JyväskyläFinlandCompleted
Kuopio University Hospital
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KuopioFinlandCompleted
Health Step Finland Oy
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KuopioFinlandCompleted
Oulu University Hospital
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OuluFinlandCompleted
TAYS Sydaenkeskus Oy
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TampereFinlandCompleted
Turku University Hospital
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TurkuFinlandCompleted
Centre Hospitalier Universitaire D'Angers
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AngersFranceCompleted
Centre Hospitalier de la Cote Basque
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BayonneFranceCompleted
Centre Hospitalier Regional Et Universitaire De Brest
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Brest Cedex 2FranceCompleted
Hospices Civils de Lyon
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BronFranceCompleted
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceCompleted
Centre Hospitalier Regional Universitaire De Tours
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Chambray Les ToursFranceCompleted
Centre Hospitalier de Cholet
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CholetFranceCompleted
Assistance Publique Hopitaux De Paris
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CreteilFranceCompleted
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceCompleted
Centre Hospitalier Departemental Vendee
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La Roche Sur Yon Cedex 9FranceCompleted
Les Hopitaux De Chartres
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Le CoudrayFranceCompleted
Centre Hospitalier De Lens
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LensFranceCompleted
Centre Hospitalier Universitaire de Limoges
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LimogesFranceCompleted
University Hospital Of Montpellier
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Montpellier Cedex 5FranceCompleted
CHRU De Nancy
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Nancy CedexFranceCompleted
L'Hopital Prive Du Confluent
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Nantes Cedex 2FranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceCompleted
University Hospitals Pitie Salpetriere - Charles Foix
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ParisFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Institut Mutualiste Montsouris
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ParisFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
Centre Hospitalier Universitaire de Rennes
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RennesFranceCompleted
CHU De Rouen
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Rouen CedexFranceCompleted
Centre Hospitalier De Saint-Brieuc
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Saint-BrieucFranceCompleted
Societe D'Exploitation Du Centre Cardiologique Du Nord
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Saint-DenisFranceCompleted
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceCompleted
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceCompleted
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
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ToulonFranceCompleted
Clinique Pasteur
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Toulouse Cedex 3FranceCompleted
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceCompleted
Centre Hospitalier De Tourcoing
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Tourcoing CedexFranceCompleted
Centre Hospitalier de Valenciennes
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ValenciennesFranceCompleted
University General Hospital of Alexandroupoli
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AlexandroupoliGreeceCompleted
General Hospital Of Athens Korgialenio Benakio H R C
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AthensGreeceCompleted
Hippokration Hospital
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AthensGreeceCompleted
Alexandra Hospital
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AthensGreeceCompleted
Laiko General Hospital of Athens
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AthensGreeceCompleted
Evaggelismos Hospital
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AthensGreeceCompleted
Athens Naval Hospital
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AthensGreeceCompleted
University General Hospital Attikon
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AthensGreeceCompleted
General Hospital of Athens "G. Gennimatas"
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AthensGreeceCompleted
General Hospital Of Eleusina Thriasio
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EleusinaGreeceCompleted
University General Hospital of Heraklion
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HeraklionGreeceCompleted
University General Hospital of Ioannina
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IoanninaGreeceCompleted
Kat Attica General Hospital
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KifissiaGreeceCompleted
General University Hospital of Larissa
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LarissaGreeceCompleted
Mitera S.A.
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MarousiGreeceCompleted
General Hospital Of Nea Ionia Konstantopouleio Patision
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Nea IoniaGreeceCompleted
General University Hospital Of Patras
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PatrasGreeceCompleted
Geniko Nosokomeio Peiraia Tzaneio
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PiraeusGreeceCompleted
Ippokratio General Hospital of Thessaloniki
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ThessalonikiGreeceCompleted
University General Hospital of Thessaloniki - AHEPA
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ThessalonikiGreeceCompleted
Asklepieion General Hospital
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VoulaGreeceCompleted
Cardiomobile Kft.
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BalatonfuredHungaryCompleted
Jahn Ferenc Del-Pesti Korhaz es Rendelointezet
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BudapestHungaryCompleted
Semmelweis University
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Budapest VIIIHungaryCompleted
Budapesti Uzsoki Utcai Korhaz
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Budapest XIVHungaryCompleted
Belinus Bt.
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DebrecenHungaryCompleted
Kardio Egeszseghaz
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GyorHungaryCompleted
Trial Pharma Kft
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GyulaHungaryCompleted
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryCompleted
Komaromi Selye Janos Korhaz
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KomáromHungaryCompleted
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
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Hospital Garcia De Orta E.P.E.
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Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
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Spitalul Clinic Colentina Bucuresti
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Spitalul Clinic De Urgenta Sf.Ioan
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Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu",
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Spitalul Clinic De Recuperare
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Spitalul Clinic Judetean De Urgenta Bihor
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Spital Judetean De Urgenta Satu Mare
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Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava
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Cardio Med S.R.L.
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Emergency Institute For Cardiovascular Diseases And Transplant
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CMI Dr Podoleanu Cristian
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Spitalul Clinic Municipal De Urgenta Timisoara
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Institutul de Boli Cardiovasculare Timișoara
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Region Dalarna
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