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A Study to Learn More About How Well BAY3018250 Works and How Safe it is for People With Proximal Deep Vein Thrombosis
Sponsor: Bayer
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.
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of BAY 3018250 in Patients With Symptomatic Proximal Deep Vein Thrombosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
283
Start Date
2024-01-15
Completion Date
2025-12-02
Last Updated
2026-07-23
Healthy Volunteers
No
Interventions
BAY3018250
Dose 1 or dose 2 of BAY3018250
Placebo to BAY3018250
Matching placebo to BAY3018250
Locations (68)
Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling
Antwerp, Belgium
Imelda - Vascular Surgery Dept
Bonheiden, Belgium
Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Thoracic Vascular Surgery Department
Genk, Belgium
UZ Gent
Ghent, Belgium
AZ Groeninge - Campus Kennedylaan
Kortrijk, Belgium
Katholieke Universiteit Leuven (KU Leuven) - Center for Molecular and Vascular Biology (CMVB)
Leuven, Belgium
AZ Sint-Maarten
Mechelen, Belgium
University Multiprofile Hospital For Active Treatment Kanev AD
Rousse, Bulgaria
Specialized Hospital For Active Cardiology Treatment Medica Kor EAD
Rousse, Bulgaria
University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD, Sofia
Sofia, Bulgaria
Medical Institute Ministry of Interior
Sofia, Bulgaria
Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department
Veliko Tarnovo, Bulgaria
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
Vojenská nemocnice Brno - Interní oddelení, pododbor kardiologie
Brno, Czechia
Interni oddeleni, Krnovska nemocnice, Sdruzene zdravotnicke zarizeni Krnov, prispevkova organizace
Krnov, Czechia
Kardiologicka klinika, Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Všeobecná fakultní nemocnice v Praze - II. interní klinika - klinika kardiologie a angiologie, AJIP
Prague, Czechia
Nemocnice Roudnice nad Labem - interni oddeleni
Roudnice nad Labem, Czechia
Interni a kardiologicka ambulance, Nemocnice Znojmo, prispevkova organizace
Znojmo, Czechia
Centre Hospitalier Universitaire Amiens Picardie Site Sud
Amiens Cedex1, France
Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche
Brest, France
Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied
Clermont-Ferrand, France
Hôpital Louis Mourier - Colombes Cedex
Colombes, France
Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon
La Tronche, France
AP-HP Hopital Europeen Georges-Pompidou (HEGP) - Service de medecine vasculaire
Paris, France
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
Saint-Etienne, France
Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC)
Strasbourg, France
Hôpital Sainte Musse
Toulon, France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil - Service de medecine vasculaire
Toulouse, France
UNIVERSITAETSKLINIKUM FREIBURG - Universitaets-Herzzentrum Bad Krozingen | Klinik für Kardiologie und Angiologie
Bad Krozingen, Germany
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
Dresden, Germany
LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV | FB Angiologie
München, Germany
Universitaetsklinikum Muenster | Klinik fuer Kardiologie I Sektion Angiologie
Münster, Germany
General Hospital Of Athens G Gennimatas- Department of Vascular Surgery
Athens, Greece
University General Hospital Attikon - 1st Department of Vascular surgery University of Athens
Athens, Greece
General Hospital Of Thessaloniki Papageorgiou- 1st Department of Surgery
Efkarpia, Greece
University General Hospital Of Ioannina- Department of Surgery, Vascular Unit Faculty
Ioannina, Greece
General University Hospital Of Patras- Department of Vascular Surgery
Pátrai, Greece
Bekes Varmegyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz
Békéscsaba, Hungary
Semmelweis Egyetem - Belgyógyászati és Hematológiai Klinika, Kardiológia
Budapest, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz - Általános Belgyógyászati Osztály
Kaposvár, Hungary
Kistarcsai Flor Ferenc Korház - II. Belgyógyászat - Angiológia
Kistarcsa, Hungary
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ - Belgyógyászati Klinika
Szeged, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz - II. Belgyogyaszat
Székesfehérvár, Hungary
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Angiologia e Malattie della Coagulazione
Bologna, Italy
Azienda Unita Locale Socio Sanitaria 2 Marca Trevigiana | Castelfranco Veneto Hospital - Angiologia Department
Castelfranco Veneto, Italy
Azienda Ospedale-Università di Padova - Medicina Generale ad indirizzo trombotico-emorragico
Padova, Italy
Azienda Unita Sanitaria Locale di Reggio Emilia | Arcispedale Santa Maria Nuova - Cardiovascular Medicine
Reggio Emilia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Malattie Emorragiche e Trombotiche
Roma, Italy
Humanitas Mirasole S.p.A. - Centro Trombosi e Malattie Emorragiche
Rozzano, Italy
AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Pronto Soccorso
Treviso, Italy
ASST dei Sette Laghi | Ospedale Di Circolo e Fondazione Macchi Di Varese - Centro Trombosi ed Emostasi
Varese, Italy
Albert Schweitzer Hospital | Internal Medicine - Hematology Department
Dordrecht, Netherlands
Zuyderland Medical Centre | Internal Medicine Department
Geleen, Netherlands
Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)
Leiden, Netherlands
Penta Hospitals | Zeleznicna Nemocnica Kosice - Angiologicka ambulancia
Košice, Slovakia
Kardiocentrum AGEL a.s. - Angiologické oddelenie
Košice, Slovakia
Nemocnicná a.s. - Interné oddelenie
Malacky, Slovakia
Penta Hospitals | Hospital and Polyclinic Spisska Nova Ves - Internal Medicine Department
Spišská Nová Ves, Slovakia
Hospitale, s.r.o. - Interné oddelenie
Šahy, Slovakia
Hospital Universitari De Girona Doctor Josep Trueta | Medicina Interna
Girona, Girona, Spain
Hospital Universitario Infanta Sofia | Medicina Interna
San Sebastián de los Reyes, Madrid, Spain
Ankara Bilkent Sehir Hastanesi
Bilkent Ankara, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
Istanbul, Turkey (Türkiye)
Saglik Bilimleri Üniversitesi Dr. Siyami Ersek Gögüs Kalp ve Damar Cerrahisi Egitim Ve Arastirma Hastanesi
Istanbul, Turkey (Türkiye)
Izmir Sehir Hastanesi
Izmir, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi
Kayseri, Turkey (Türkiye)