A Study to Learn More About How Well BAY3018250 Works and How Safe it is for People With Proximal Deep Vein Thrombosis

Last updated: March 24, 2025
Sponsor: Bayer
Overall Status: Active - Recruiting

Phase

2

Condition

Venous Thrombosis

Claudication

Thrombosis

Treatment

Placebo to BAY3018250

BAY3018250

Clinical Study ID

NCT06149520
22138
2023-503315-15-00
  • Ages > 18
  • All Genders

Study Summary

Researchers are looking for a better way to treat people who have deep vein thrombosis (DVT).

DVT is a condition that occurs when a blood clot forms in a deep vein in the leg. DVT is called 'proximal' when the clot is formed in the veins of the hip, thigh, and knee. DVT can cause serious health problems. The blood clots in the veins can break loose and can then travel through the bloodstream and get stuck in the lungs, blocking blood flow to the lungs. Symptoms of DVT include swelling, pain, and tenderness in the affected leg, as well as redness and warmth in the area. Currently, DVT is usually treated using blood thinners to prevent the clot from getting bigger or breaking off and traveling to the lungs. However, blood thinners may not be able to remove a blood clot quickly and may not be suitable for everyone who has DVT.

BAY3018250 is a drug that works by dissolving blood clots. In this study, researchers will compare BAY3018250 with placebo to learn how well it works and how safe it is in participants with proximal DVT. A placebo looks like the study drug but does not have any medicine in it. Using a placebo helps researchers to confirm that the results observed during the study were caused by the study drug and not by other factors.

The main purposes of this study are to learn:

  • How well BAY3018250 works in dissolving blood clots in participants with proximal DVT and

  • How safe is BAY3018250 as a treatment for participants with proximal DVT?

For this, the researchers will use ultrasound tests to measure blood clots in participants before and at various times after study treatment. They call these measurements a clot burden score. They will compare the clot burden score before and after treatment and will calculate a complex measure called AUC. This tells researchers how the clots have changed over time.

And researchers will collect the number of bleeding events that require medical attention.

The study participants will be randomly (by chance) assigned to one of 3 treatment groups. Dependent on the group, they will receive a single dose of high dose or low dose of BAY3018250 or placebo.

Researchers will closely monitor participants for 90 days after receiving the study treatment.

During the study, the doctors and their study team will:

  • take blood samples

  • do physical examinations

  • examine heart health using electrocardiogram (ECG)

  • check vital signs such as blood pressure, heart rate

  • undergo ultrasound tests to measure the blood clots

  • ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

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

Total Participants: 255
Treatment Group(s): 2
Primary Treatment: Placebo to BAY3018250
Phase: 2
Study Start date:
January 15, 2024
Estimated Completion Date:
October 06, 2025

Connect with a study center

  • Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling

    Antwerp, 2650
    Belgium

    Active - Recruiting

  • Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling

    Antwerpen, 2000
    Belgium

    Site Not Available

  • Imelda - Vascular Surgery Dept

    Bonheiden, 2820
    Belgium

    Active - Recruiting

  • AZ Sint-Maarten

    Duffel, 2570
    Belgium

    Site Not Available

  • Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling

    Edegem, 2650
    Belgium

    Site Not Available

  • Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Thoracic Vascular Surgery Department

    Genk, 3600
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • AZ Groeninge - Campus Kennedylaan

    Kortrijk, 8500
    Belgium

    Active - Recruiting

  • Katholieke Universiteit Leuven (KU Leuven) - Center for Molecular and Vascular Biology (CMVB)

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman

    Liege, 4000
    Belgium

    Site Not Available

  • AZ Sint-Maarten

    Mechelen, 2800
    Belgium

    Active - Recruiting

  • Specialized Hospital For Active Cardiology Treatment Medica Kor EAD

    Ruse, 7013
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital For Active Treatment Kanev AD

    Ruse, 7002
    Bulgaria

    Active - Recruiting

  • MHAT National Heart Hospital EAD

    Sofia, 1309
    Bulgaria

    Site Not Available

  • Medical Institute Ministry of Interior

    Sofia, 1606
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD

    Sofia, 1431
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital For Active Treatment 'Sveta Ekaterina' EAD

    Sofia, 1431
    Bulgaria

    Active - Recruiting

  • Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Cardiology Department

    Veliko Tarnovo, 5000
    Bulgaria

    Active - Recruiting

  • Niagara Health - St. Catharines Site

    St. Catharines, Ontario L2S 0A9
    Canada

    Site Not Available

  • McGill University Health Centre - Glen Site

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Hamilton Health Sciences - Hamilton General Hospital (HGH)

    Hamilton, L8L 2X2
    Canada

    Site Not Available

  • II. interni klinika, Cevni ambulance (angiologicka ambulance), Fakultni nemocnice u sv. Anny v Brne

    Brno, 602 00
    Czechia

    Site Not Available

  • Vojenska nemocnice Brno - kardiologicke interni oddeleni

    Brno, 615 00
    Czechia

    Active - Recruiting

  • Interni oddeleni, Krnovska nemocnice, Sdruzene zdravotnicke zarizeni Krnov, prispevkova organizace

    Krnov, 794 01
    Czechia

    Active - Recruiting

  • Nemocnice Mlada Boleslav - interni oddeleni

    Mlada Boleslav, 293 01
    Czechia

    Site Not Available

  • Oblastni nemocnice Mlada Boleslav

    Mlada Boleslav, 293 01
    Czechia

    Site Not Available

  • Kardiologicka a interni ambulance - Ostrava

    Ostrava, 70852
    Czechia

    Site Not Available

  • Kardiologicka klinika, Fakultni nemocnice Kralovske Vinohrady

    Praha 10, 100 34
    Czechia

    Active - Recruiting

  • II. interni klinika - klinika kardiologie a angiologie 1. lekarske fakulty a Vseobecne fakultni nemocnice

    Praha 2, 128 08
    Czechia

    Active - Recruiting

  • Oddeleni standardni kardiologie, Nemocnice Na Homolce

    Praha 5, 150 30
    Czechia

    Site Not Available

  • Nemocnice Roudnice nad Labem

    Roudnice nad Labem, 41301
    Czechia

    Site Not Available

  • Nemocnice Roudnice nad Labem - interni oddeleni

    Roudnice nad Labem, 41301
    Czechia

    Site Not Available

  • Krajská zdravotní, Masarykova nemocnice Ústí nad Labem - Kardiologická jednotka intenzivní péce

    Usti nad Labem, 400 11
    Czechia

    Suspended

  • Masaryk Hospital Usti n/L - Kardiologicka jednotka intenzivni pece

    Usti nad Labem, 400 11
    Czechia

    Suspended

  • Interni a kardiologicka ambulance, Nemocnice Znojmo, prispevkova organizace

    Znojmo, 669 02
    Czechia

    Site Not Available

  • Groupe Hospitalier Sud - Amiens

    AMIENS cedex1, 80054
    France

    Active - Recruiting

  • Groupe Hospitalier Sud - Amiens

    Amiens, 80000
    France

    Site Not Available

  • Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche

    Brest, 29609
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied

    Clermont Ferrand, 63003
    France

    Active - Recruiting

  • Hôpital Louis Mourier - Colombes Cedex

    Colombes, 92701
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon

    La Tronche, 38700
    France

    Site Not Available

  • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Europeen Georges-Pompidou (HEGP)

    Paris, 75908
    France

    Active - Recruiting

  • CHU Rennes, H Pontchaillou, Cardiologie

    Rennes, 35033
    France

    Site Not Available

  • Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

    Saint Etienne, 42000
    France

    Active - Recruiting

  • Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC)

    Strasbourg, 67091
    France

    Active - Recruiting

  • Hôpital Font Pré - Toulon

    Toulon, 83000
    France

    Site Not Available

  • Hôpital Sainte Musse

    Toulon, 83100
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil

    Toulouse, 31059
    France

    Active - Recruiting

  • UNIVERSITAETSKLINIKUM FREIBURG - Universitaets-Herzzentrum Bad Krozingen | Klinik für Kardiologie und Angiologie

    Bad Krozingen, 79189
    Germany

    Site Not Available

  • Charité Universitaetsmedizin Berlin - Campus Benjamin Franklin | Med. Klinik fuer Kardiologie, Angiologie und Intensivmedizin

    Berlin, 12203
    Germany

    Site Not Available

  • Franziskus-Krankenhaus Berlin | Klinik für Innere Medizin

    Berlin, 10787
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie

    Dresden, 01307
    Germany

    Active - Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf | II. Medizinische Klinik und Poliklinik - Bereich Haemostaseologie

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg-Eppendorf | II. Medizinische Klinik und Poliklinik | Bereich Haemostaseologie

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Zentrum fuer Kardiologie - Kardiologie III - Angiologie

    Mainz, 55131
    Germany

    Site Not Available

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Zentrum fuer Kardiologie - Kardiologie III | Angiologie

    Mainz, 55131
    Germany

    Site Not Available

  • LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV - FB Angiologie

    Muenchen, 80336
    Germany

    Site Not Available

  • LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV | FB Angiologie

    Muenchen, 80336
    Germany

    Active - Recruiting

  • Universitaetsklinikum Muenster | Klinik fuer Kardiologie I - Sektion Angiologie

    Muenster, 48149 Münster
    Germany

    Suspended

  • Universitaetsklinikum Muenster | Klinik fuer Kardiologie I Sektion Angiologie

    Muenster, 48149 Münster
    Germany

    Suspended

  • General Hospital Of Athens G Gennimatas- Department of Vascular Surgery

    Athens, 115 27
    Greece

    Site Not Available

  • University General Hospital Attikon - 1st Department of Vascular surgery University of Athens

    Athens, 124 62
    Greece

    Site Not Available

  • General Hospital Of Thessaloniki Papageorgiou- 1st Department of Surgery

    Efkarpia, 564 29
    Greece

    Site Not Available

  • University General Hospital Of Ioannina- Department of Surgery, Vascular Unit Faculty

    Ioannina, 455 00
    Greece

    Active - Recruiting

  • University General Hospital of Larissa - Department of Vascular surgery of University of Thessaly

    Larissa, 41110
    Greece

    Site Not Available

  • General University Hospital Of Patras- Department of Vascular Surgery

    Patras, 265 04
    Greece

    Active - Recruiting

  • Semmelweis Egyetem - Belgyógyászati és Hematológiai Klinika, Kardiológia

    Budapest, 1088
    Hungary

    Site Not Available

  • Bekes Varmegyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz

    Békéscsaba, 5600
    Hungary

    Site Not Available

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz - Általános Belgyógyászati Osztály

    Kaposvár, 7400
    Hungary

    Active - Recruiting

  • Kistarcsai Flor Ferenc Korház - II. Belgyógyászat - Angiológia

    Kistarcsa, 2143
    Hungary

    Active - Recruiting

  • Borsod-Abauj-Zemplen Varmegyei Korhaz es Egyetemi Oktatokorhaz - Kardiovaszkularis es Belgyogyaszati centrum

    Miskolc, 3526
    Hungary

    Site Not Available

  • Pecsi Tudomanyegyetem Klinikai Kozpont - I. sz. Belgyogyaszati Klinika

    Pecs, 7624
    Hungary

    Site Not Available

  • Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ - Belgyógyászati Klinika

    Szeged, 6725
    Hungary

    Site Not Available

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz - II. Belgyogyaszat

    Székesfehérvár, 8000
    Hungary

    Site Not Available

  • Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Angiologia e Malattie della Coagulazione

    Bologna, 40138
    Italy

    Active - Recruiting

  • Azienda Unita Locale Socio Sanitaria 2 Marca Trevigiana | Castelfranco Veneto Hospital - Angiologia Department

    Castelfranco Veneto, <unknown>
    Italy

    Active - Recruiting

  • Azienda Ospedale-Università di Padova - Medicina Generale ad indirizzo trombotico-emorragico

    Padova, 35128
    Italy

    Active - Recruiting

  • Universita degli Studi di Padova - Azienda Ospedaliera di Padova

    Padua, 35128
    Italy

    Site Not Available

  • Azienda Unita Sanitaria Locale di Reggio Emilia | Arcispedale Santa Maria Nuova - Cardiovascular Medicine

    Reggio Emilia, 42122
    Italy

    Active - Recruiting

  • Servizio Sanitario Regionale Emilia-Romagna - Azienda Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova (ASMN)

    Reggio Emilia, 42122
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Malattie Emorragiche e Trombotiche

    Roma, 00168
    Italy

    Active - Recruiting

  • Universita Cattolica del Sacro Cuore - Policlinico Universitario "Agostino Gemelli"

    Rome, 00168
    Italy

    Site Not Available

  • Gruppo Humanitas - Humanitas Research Hospital - Centro Trombosi

    Rozzano, 20089
    Italy

    Site Not Available

  • Humanitas Mirasole S.p.A. - Centro Trombosi e Malattie Emorragiche

    Rozzano, 20089
    Italy

    Active - Recruiting

  • AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Pronto Soccorso

    Treviso, 31100
    Italy

    Active - Recruiting

  • Azienda Unita Locale Socio Sanitaria (ULSS) 2 Marca trevigiana - Ospedale Treviso

    Treviso, 31100
    Italy

    Active - Recruiting

  • ASST dei Sette Laghi | Ospedale Di Circolo e Fondazione Macchi Di Varese - Centro Trombosi ed Emostasi

    Varese, 21100
    Italy

    Site Not Available

  • Rijnstate | Arnhem - Internal Medicine Department - Vascular Research

    Arnhem, 6815 AD
    Netherlands

    Site Not Available

  • Albert Schweitzer Hospital | Internal Medicine - Hematology Department

    Dordrecht, 3318 AT
    Netherlands

    Active - Recruiting

  • Albert Schweitzer Ziekenhuis - Dordwijk

    Dordrecht, 3300 AK
    Netherlands

    Site Not Available

  • Zuyderland Medical Centre | Internal Medicine Department

    Geleen, 6162 BG
    Netherlands

    Active - Recruiting

  • Zuyderland Medisch Centrum Sittard-Geleen

    Geleen, 6162 BG
    Netherlands

    Site Not Available

  • Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)

    Leiden, 2300 RC
    Netherlands

    Active - Recruiting

  • Maastricht University Medical Center | School for Cardiovascular Diseases - Biochemie

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Universiteit Maastricht (UM) - Maastricht University Medical Centre (Maastricht UMC+)

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Radboud Universitair Medisch Centrum (Radboudumc) (Radboud University Medical Center)

    Nijmegen, 6500 HB
    Netherlands

    Site Not Available

  • Radboud University Medical Center | Afdeling Interne Geneeskunde

    Nijmegen, 6500 HB
    Netherlands

    Site Not Available

  • Isala

    Zwolle, 8025AB
    Netherlands

    Site Not Available

  • Stredoslovenský ústav srdcových a cievnych chorôb, a.s. - Oddelenie angiológie

    Banská Bystrica, 974 01
    Slovakia

    Site Not Available

  • Penta Hospitals | Nemocnica Bory - Department of Internal Medicine

    Bratislava, 841 03
    Slovakia

    Suspended

  • Kardiocentrum AGEL a.s.

    Košice, 040 15
    Slovakia

    Site Not Available

  • Kardiocentrum AGEL a.s. - Angiologické oddelenie

    Košice, 040 15
    Slovakia

    Active - Recruiting

  • Penta Hospitals | Zeleznicna Nemocnica Kosice - Angiologicka ambulancia

    Košice, 040 01
    Slovakia

    Active - Recruiting

  • Železnicné zdravotníctvo Košice, s.r.o. - Angiologická ambulancia

    Košice, 040 01
    Slovakia

    Site Not Available

  • Nemocnicná a.s. - Interné oddelenie

    Malacky, 901 22
    Slovakia

    Active - Recruiting

  • Penta Hospitals SK, a. s., Všeobecná nemocnica Rimavská Sobota - Oddelenie vnútorného lekárstva

    Rimavská Sobota, 979 01
    Slovakia

    Site Not Available

  • Penta Hospitals | Rimavska Sobota Hospital - Internal Medicine Department

    Rimavská Sobota, 979 01
    Slovakia

    Site Not Available

  • Nemocnica s poliklinikou Spišská Nová Ves, a.s. - Oddelenie vnútorného lekárstva

    Spišská Nová Ves, 052 01
    Slovakia

    Site Not Available

  • Penta Hospitals | Hospital and Polyclinic Spisska Nova Ves - Internal Medicine Department

    Spišská Nová Ves, 052 01
    Slovakia

    Site Not Available

  • Hospitale, s.r.o. - Interné oddelenie

    Šahy, 936 01
    Slovakia

    Active - Recruiting

  • Hospital Universitario Infanta Sofia-Medicina Interna

    San Sebastian de los Reyes, Madrid 28702
    Spain

    Site Not Available

  • Hospital Universitari De Girona Doctor Josep Trueta-Medicina Interna

    Girona, 17007
    Spain

    Active - Recruiting

  • Hospital Universitario la Paz-Medicina Interna

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario de Navarra- Medicina Interna

    Pamplona, 31008
    Spain

    Site Not Available

  • Ankara Bilkent Sehir Hastanesi

    Bilkent Ankara, 6800
    Turkey

    Site Not Available

  • Ankara Bilkent Sehir Hastanesi

    Bilkent Çankaya, 6800
    Turkey

    Site Not Available

  • Bagcilar Egitim ve Arastirma Hastanesi

    Istanbul, 34200
    Turkey

    Site Not Available

  • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospit

    Istanbul, 34846
    Turkey

    Suspended

  • Saglik Bilimleri Üniversitesi Dr. Siyami Ersek Gögüs Kalp ve Damar Cerrahisi Egitim Ve Arastirma Hastanesi

    Istanbul, 34744
    Turkey

    Active - Recruiting

  • Izmir Sehir Hastanesi

    Izmir, 35540
    Turkey

    Active - Recruiting

  • Erciyes Universitesi Tip Fakultesi

    Kayseri, 38039
    Turkey

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.