Phase
Condition
Venous Thrombosis
Claudication
Thrombosis
Treatment
Placebo to BAY3018250
BAY3018250
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female (if postmenopausal or hysterectomized) aged 18 years or older
Acute symptomatic proximal deep vein thrombosis (DVT) documented by compressionultrasound (CUS) and all of the following:
duration of symptoms 14 days or less
Proximal DVT involving at least 1 of the following proximal veins: thepopliteal vein, the femoral vein, the common femoral vein and the externaliliac vein
adequate visualization of the most proximal end of the thrombus
receiving therapeutic dose anticoagulation with low molecular weight heparins (LMWHs) and/or direct oral anticoagulants (DOACs) according to the respectiveproduct labels
Measured body weight within 50 to 130 kg
Signed informed consent
Exclusion
Exclusion Criteria:
Acute symptomatic pulmonary embolism (PE) requiring systemic or catheter-directedthrombolytic therapy, catheter-directed mechanical thrombectomy, or surgicalembolectomy
Active bleeding or high risk for bleeding (at the discretion of the investigator)
Recent (<3 months) ischemic stroke, myocardial infarction, intracranial hemorrhage,or major surgery or severe trauma (at the discretion of the investigator)
Active cancer, i.e., locally active, regionally invasive or metastatic and/oranticancer therapy within the last 6 months, except basal cell or squamous cellcarcinoma
Therapeutic-dose anticoagulants for > 72 hours before randomization, or current useof vitamin K antagonists
Planned or current use of the following medications:
Any antiplatelet therapy, except acetylsalicylic acid (ASA) ≤100 mg/day
Antifibrinolytic drugs
Therapeutic antibodies
Male participants with women of childbearing potential (WOCBP) partners unwilling touse highly effective contraception from start of study intervention until end ofstudy.
Study Design
Connect with a study center
Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling
Antwerp, 2650
BelgiumActive - Recruiting
Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling
Antwerpen, 2000
BelgiumSite Not Available
Imelda - Vascular Surgery Dept
Bonheiden, 2820
BelgiumActive - Recruiting
AZ Sint-Maarten
Duffel, 2570
BelgiumSite Not Available
Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling
Edegem, 2650
BelgiumSite Not Available
Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Thoracic Vascular Surgery Department
Genk, 3600
BelgiumActive - Recruiting
UZ Gent
Gent, 9000
BelgiumActive - Recruiting
AZ Groeninge - Campus Kennedylaan
Kortrijk, 8500
BelgiumActive - Recruiting
Katholieke Universiteit Leuven (KU Leuven) - Center for Molecular and Vascular Biology (CMVB)
Leuven, 3000
BelgiumActive - Recruiting
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
Liege, 4000
BelgiumSite Not Available
AZ Sint-Maarten
Mechelen, 2800
BelgiumActive - Recruiting
Specialized Hospital For Active Cardiology Treatment Medica Kor EAD
Ruse, 7013
BulgariaSite Not Available
University Multiprofile Hospital For Active Treatment Kanev AD
Ruse, 7002
BulgariaActive - Recruiting
MHAT National Heart Hospital EAD
Sofia, 1309
BulgariaSite Not Available
Medical Institute Ministry of Interior
Sofia, 1606
BulgariaSite Not Available
University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD
Sofia, 1431
BulgariaSite Not Available
University Multiprofile Hospital For Active Treatment 'Sveta Ekaterina' EAD
Sofia, 1431
BulgariaActive - Recruiting
Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Cardiology Department
Veliko Tarnovo, 5000
BulgariaActive - Recruiting
Niagara Health - St. Catharines Site
St. Catharines, Ontario L2S 0A9
CanadaSite Not Available
McGill University Health Centre - Glen Site
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Hamilton Health Sciences - Hamilton General Hospital (HGH)
Hamilton, L8L 2X2
CanadaSite Not Available
II. interni klinika, Cevni ambulance (angiologicka ambulance), Fakultni nemocnice u sv. Anny v Brne
Brno, 602 00
CzechiaSite Not Available
Vojenska nemocnice Brno - kardiologicke interni oddeleni
Brno, 615 00
CzechiaActive - Recruiting
Interni oddeleni, Krnovska nemocnice, Sdruzene zdravotnicke zarizeni Krnov, prispevkova organizace
Krnov, 794 01
CzechiaActive - Recruiting
Nemocnice Mlada Boleslav - interni oddeleni
Mlada Boleslav, 293 01
CzechiaSite Not Available
Oblastni nemocnice Mlada Boleslav
Mlada Boleslav, 293 01
CzechiaSite Not Available
Kardiologicka a interni ambulance - Ostrava
Ostrava, 70852
CzechiaSite Not Available
Kardiologicka klinika, Fakultni nemocnice Kralovske Vinohrady
Praha 10, 100 34
CzechiaActive - Recruiting
II. interni klinika - klinika kardiologie a angiologie 1. lekarske fakulty a Vseobecne fakultni nemocnice
Praha 2, 128 08
CzechiaActive - Recruiting
Oddeleni standardni kardiologie, Nemocnice Na Homolce
Praha 5, 150 30
CzechiaSite Not Available
Nemocnice Roudnice nad Labem
Roudnice nad Labem, 41301
CzechiaSite Not Available
Nemocnice Roudnice nad Labem - interni oddeleni
Roudnice nad Labem, 41301
CzechiaSite Not Available
Krajská zdravotní, Masarykova nemocnice Ústí nad Labem - Kardiologická jednotka intenzivní péce
Usti nad Labem, 400 11
CzechiaSuspended
Masaryk Hospital Usti n/L - Kardiologicka jednotka intenzivni pece
Usti nad Labem, 400 11
CzechiaSuspended
Interni a kardiologicka ambulance, Nemocnice Znojmo, prispevkova organizace
Znojmo, 669 02
CzechiaSite Not Available
Groupe Hospitalier Sud - Amiens
AMIENS cedex1, 80054
FranceActive - Recruiting
Groupe Hospitalier Sud - Amiens
Amiens, 80000
FranceSite Not Available
Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche
Brest, 29609
FranceActive - Recruiting
Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied
Clermont Ferrand, 63003
FranceActive - Recruiting
Hôpital Louis Mourier - Colombes Cedex
Colombes, 92701
FranceActive - Recruiting
Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon
La Tronche, 38700
FranceSite Not Available
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Europeen Georges-Pompidou (HEGP)
Paris, 75908
FranceActive - Recruiting
CHU Rennes, H Pontchaillou, Cardiologie
Rennes, 35033
FranceSite Not Available
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
Saint Etienne, 42000
FranceActive - Recruiting
Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC)
Strasbourg, 67091
FranceActive - Recruiting
Hôpital Font Pré - Toulon
Toulon, 83000
FranceSite Not Available
Hôpital Sainte Musse
Toulon, 83100
FranceActive - Recruiting
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil
Toulouse, 31059
FranceActive - Recruiting
UNIVERSITAETSKLINIKUM FREIBURG - Universitaets-Herzzentrum Bad Krozingen | Klinik für Kardiologie und Angiologie
Bad Krozingen, 79189
GermanySite Not Available
Charité Universitaetsmedizin Berlin - Campus Benjamin Franklin | Med. Klinik fuer Kardiologie, Angiologie und Intensivmedizin
Berlin, 12203
GermanySite Not Available
Franziskus-Krankenhaus Berlin | Klinik für Innere Medizin
Berlin, 10787
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
Dresden, 01307
GermanyActive - Recruiting
Universitaetsklinikum Hamburg-Eppendorf | II. Medizinische Klinik und Poliklinik - Bereich Haemostaseologie
Hamburg, 20246
GermanySite Not Available
Universitaetsklinikum Hamburg-Eppendorf | II. Medizinische Klinik und Poliklinik | Bereich Haemostaseologie
Hamburg, 20246
GermanySite Not Available
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Zentrum fuer Kardiologie - Kardiologie III - Angiologie
Mainz, 55131
GermanySite Not Available
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Zentrum fuer Kardiologie - Kardiologie III | Angiologie
Mainz, 55131
GermanySite Not Available
LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV - FB Angiologie
Muenchen, 80336
GermanySite Not Available
LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV | FB Angiologie
Muenchen, 80336
GermanyActive - Recruiting
Universitaetsklinikum Muenster | Klinik fuer Kardiologie I - Sektion Angiologie
Muenster, 48149 Münster
GermanySuspended
Universitaetsklinikum Muenster | Klinik fuer Kardiologie I Sektion Angiologie
Muenster, 48149 Münster
GermanySuspended
General Hospital Of Athens G Gennimatas- Department of Vascular Surgery
Athens, 115 27
GreeceSite Not Available
University General Hospital Attikon - 1st Department of Vascular surgery University of Athens
Athens, 124 62
GreeceSite Not Available
General Hospital Of Thessaloniki Papageorgiou- 1st Department of Surgery
Efkarpia, 564 29
GreeceSite Not Available
University General Hospital Of Ioannina- Department of Surgery, Vascular Unit Faculty
Ioannina, 455 00
GreeceActive - Recruiting
University General Hospital of Larissa - Department of Vascular surgery of University of Thessaly
Larissa, 41110
GreeceSite Not Available
General University Hospital Of Patras- Department of Vascular Surgery
Patras, 265 04
GreeceActive - Recruiting
Semmelweis Egyetem - Belgyógyászati és Hematológiai Klinika, Kardiológia
Budapest, 1088
HungarySite Not Available
Bekes Varmegyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz
Békéscsaba, 5600
HungarySite Not Available
Somogy Varmegyei Kaposi Mor Oktato Korhaz - Általános Belgyógyászati Osztály
Kaposvár, 7400
HungaryActive - Recruiting
Kistarcsai Flor Ferenc Korház - II. Belgyógyászat - Angiológia
Kistarcsa, 2143
HungaryActive - Recruiting
Borsod-Abauj-Zemplen Varmegyei Korhaz es Egyetemi Oktatokorhaz - Kardiovaszkularis es Belgyogyaszati centrum
Miskolc, 3526
HungarySite Not Available
Pecsi Tudomanyegyetem Klinikai Kozpont - I. sz. Belgyogyaszati Klinika
Pecs, 7624
HungarySite Not Available
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ - Belgyógyászati Klinika
Szeged, 6725
HungarySite Not Available
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz - II. Belgyogyaszat
Székesfehérvár, 8000
HungarySite Not Available
Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi
Bologna, 40138
ItalySite Not Available
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Angiologia e Malattie della Coagulazione
Bologna, 40138
ItalyActive - Recruiting
Azienda Unita Locale Socio Sanitaria 2 Marca Trevigiana | Castelfranco Veneto Hospital - Angiologia Department
Castelfranco Veneto, <unknown>
ItalyActive - Recruiting
Azienda Ospedale-Università di Padova - Medicina Generale ad indirizzo trombotico-emorragico
Padova, 35128
ItalyActive - Recruiting
Universita degli Studi di Padova - Azienda Ospedaliera di Padova
Padua, 35128
ItalySite Not Available
Azienda Unita Sanitaria Locale di Reggio Emilia | Arcispedale Santa Maria Nuova - Cardiovascular Medicine
Reggio Emilia, 42122
ItalyActive - Recruiting
Servizio Sanitario Regionale Emilia-Romagna - Azienda Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova (ASMN)
Reggio Emilia, 42122
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Malattie Emorragiche e Trombotiche
Roma, 00168
ItalyActive - Recruiting
Universita Cattolica del Sacro Cuore - Policlinico Universitario "Agostino Gemelli"
Rome, 00168
ItalySite Not Available
Gruppo Humanitas - Humanitas Research Hospital - Centro Trombosi
Rozzano, 20089
ItalySite Not Available
Humanitas Mirasole S.p.A. - Centro Trombosi e Malattie Emorragiche
Rozzano, 20089
ItalyActive - Recruiting
AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Pronto Soccorso
Treviso, 31100
ItalyActive - Recruiting
Azienda Unita Locale Socio Sanitaria (ULSS) 2 Marca trevigiana - Ospedale Treviso
Treviso, 31100
ItalyActive - Recruiting
ASST dei Sette Laghi | Ospedale Di Circolo e Fondazione Macchi Di Varese - Centro Trombosi ed Emostasi
Varese, 21100
ItalySite Not Available
Rijnstate | Arnhem - Internal Medicine Department - Vascular Research
Arnhem, 6815 AD
NetherlandsSite Not Available
Albert Schweitzer Hospital | Internal Medicine - Hematology Department
Dordrecht, 3318 AT
NetherlandsActive - Recruiting
Albert Schweitzer Ziekenhuis - Dordwijk
Dordrecht, 3300 AK
NetherlandsSite Not Available
Zuyderland Medical Centre | Internal Medicine Department
Geleen, 6162 BG
NetherlandsActive - Recruiting
Zuyderland Medisch Centrum Sittard-Geleen
Geleen, 6162 BG
NetherlandsSite Not Available
Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)
Leiden, 2300 RC
NetherlandsActive - Recruiting
Maastricht University Medical Center | School for Cardiovascular Diseases - Biochemie
Maastricht, 6229 HX
NetherlandsSite Not Available
Universiteit Maastricht (UM) - Maastricht University Medical Centre (Maastricht UMC+)
Maastricht, 6229 HX
NetherlandsSite Not Available
Radboud Universitair Medisch Centrum (Radboudumc) (Radboud University Medical Center)
Nijmegen, 6500 HB
NetherlandsSite Not Available
Radboud University Medical Center | Afdeling Interne Geneeskunde
Nijmegen, 6500 HB
NetherlandsSite Not Available
Isala
Zwolle, 8025AB
NetherlandsSite Not Available
Stredoslovenský ústav srdcových a cievnych chorôb, a.s. - Oddelenie angiológie
Banská Bystrica, 974 01
SlovakiaSite Not Available
Penta Hospitals | Nemocnica Bory - Department of Internal Medicine
Bratislava, 841 03
SlovakiaSuspended
Kardiocentrum AGEL a.s.
Košice, 040 15
SlovakiaSite Not Available
Kardiocentrum AGEL a.s. - Angiologické oddelenie
Košice, 040 15
SlovakiaActive - Recruiting
Penta Hospitals | Zeleznicna Nemocnica Kosice - Angiologicka ambulancia
Košice, 040 01
SlovakiaActive - Recruiting
Železnicné zdravotníctvo Košice, s.r.o. - Angiologická ambulancia
Košice, 040 01
SlovakiaSite Not Available
Nemocnicná a.s. - Interné oddelenie
Malacky, 901 22
SlovakiaActive - Recruiting
Penta Hospitals SK, a. s., Všeobecná nemocnica Rimavská Sobota - Oddelenie vnútorného lekárstva
Rimavská Sobota, 979 01
SlovakiaSite Not Available
Penta Hospitals | Rimavska Sobota Hospital - Internal Medicine Department
Rimavská Sobota, 979 01
SlovakiaSite Not Available
Nemocnica s poliklinikou Spišská Nová Ves, a.s. - Oddelenie vnútorného lekárstva
Spišská Nová Ves, 052 01
SlovakiaSite Not Available
Penta Hospitals | Hospital and Polyclinic Spisska Nova Ves - Internal Medicine Department
Spišská Nová Ves, 052 01
SlovakiaSite Not Available
Hospitale, s.r.o. - Interné oddelenie
Šahy, 936 01
SlovakiaActive - Recruiting
Hospital Universitario Infanta Sofia-Medicina Interna
San Sebastian de los Reyes, Madrid 28702
SpainSite Not Available
Hospital Universitari De Girona Doctor Josep Trueta-Medicina Interna
Girona, 17007
SpainActive - Recruiting
Hospital Universitario la Paz-Medicina Interna
Madrid, 28046
SpainSite Not Available
Hospital Universitario de Navarra- Medicina Interna
Pamplona, 31008
SpainSite Not Available
Ankara Bilkent Sehir Hastanesi
Bilkent Ankara, 6800
TurkeySite Not Available
Ankara Bilkent Sehir Hastanesi
Bilkent Çankaya, 6800
TurkeySite Not Available
Bagcilar Egitim ve Arastirma Hastanesi
Istanbul, 34200
TurkeySite Not Available
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
Istanbul, 34098
TurkeyActive - Recruiting
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospit
Istanbul, 34846
TurkeySuspended
Saglik Bilimleri Üniversitesi Dr. Siyami Ersek Gögüs Kalp ve Damar Cerrahisi Egitim Ve Arastirma Hastanesi
Istanbul, 34744
TurkeyActive - Recruiting
Izmir Sehir Hastanesi
Izmir, 35540
TurkeyActive - Recruiting
Erciyes Universitesi Tip Fakultesi
Kayseri, 38039
TurkeyActive - Recruiting
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