A Study to Learn More About How Well BAY3018250 Works and How Safe it is for People With Proximal Deep Vein Thrombosis
- Conditions
- ThrombolysisSymptomatic Proximal Deep Vein Thrombosis
- Interventions
- Drug: Placebo to BAY3018250
- Registration Number
- NCT06149520
- Lead Sponsor
- Bayer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 255
-
Male and female (if postmenopausal or hysterectomized) aged 18 years or older
-
Acute symptomatic proximal deep vein thrombosis (DVT) documented by compression ultrasound (CUS) and all of the following:
- duration of symptoms 14 days or less
- Proximal DVT involving at least 1 of the following proximal veins: the popliteal vein, the femoral vein, the common femoral vein and the external iliac 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 respective product labels
-
Measured body weight within 50 to 130 kg
-
Signed informed consent
-
Acute symptomatic pulmonary embolism (PE) requiring systemic or catheter-directed thrombolytic therapy, catheter-directed mechanical thrombectomy, or surgical embolectomy
-
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/or anticancer therapy within the last 6 months, except basal cell or squamous cell carcinoma
-
Therapeutic-dose anticoagulants for > 72 hours before randomization, or current use of 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 to use highly effective contraception from start of study intervention until end of study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BAY3018250 Dose 1 BAY3018250 Participants will receive BAY3018250 Dose 1. Placebo to BAY3018250 Placebo to BAY3018250 Participants will receive placebo to BAY3018250. BAY3018250 Dose 2 BAY3018250 Participants will receive BAY3018250 Dose 2.
- Primary Outcome Measures
Name Time Method Number of participants with composite of major and clinically relevant non-major (CRNM) bleeding events (ISTH definition) up to Day 15 The classify of bleeding events use the International Society on Thrombosis and Haemostasis (ISTH) definitions.
AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound at 6 hours, 24 hours, Day 7, Day 30 Area under the curve (AUC) with respect to the measurement time points at 6 hours, 24 hours, 7 days and 30 days of the ratio to baseline of clot burden
- Secondary Outcome Measures
Name Time Method Ratio to baseline of clot burden, as assessed by quantitative ultrasound at 6 hours, 24 hours, Day 7, Day 30 and Day 90 Change from baseline in leg pain severity at 6 hours, 24 hours, Day 7, Day 30 and Day 90 Likert pain scale is used as a quantitative measure of patient reported pain based on the participant´s judgement. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
Change from baseline in PVFS scale at Day 7, Day 30 and Day 90 PVFS stands for post venous thromboembolism functional status. PVFS scale is ordinal, has 6 steps ranging from 0 (no symptoms) to 5 (death), with higher scores being worse and covers the entire range of functional outcomes by focusing on limitations in usual duties/activities either at home or at work/study, as well as changes in lifestyle.
Number of participants with recurrent venous thromboembolism up to Day 90
Trial Locations
- Locations (96)
Azienda Unita Locale Socio Sanitaria 2 Marca Trevigiana | Castelfranco Veneto Hospital - Angiologia Department
🇮🇹Castelfranco Veneto, Italy
Radboud University Medical Center | Afdeling Interne Geneeskunde
🇳🇱Nijmegen, Netherlands
Isala
🇳🇱Zwolle, Netherlands
Penta Hospitals | Zeleznicna Nemocnica Kosice - Angiologicka ambulancia
🇸🇰Košice, Slovakia
Penta Hospitals | Hospital and Polyclinic Spisska Nova Ves - Internal Medicine Department
🇸🇰Spišská Nová Ves, Slovakia
Hospital Universitario la Paz-Medicina Interna
🇪🇸Madrid, Spain
Azienda Unita Sanitaria Locale di Reggio Emilia | Arcispedale Santa Maria Nuova - Cardiovascular Medicine
🇮🇹Reggio Emilia, Italy
Humanitas Mirasole S.p.A. - Centro Trombosi e Malattie Emorragiche
🇮🇹Rozzano, Italy
Rijnstate | Arnhem - Internal Medicine Department - Vascular Research
🇳🇱Arnhem, Netherlands
Kardiocentrum AGEL a.s. - Angiologické oddelenie
🇸🇰Košice, Slovakia
Nemocnicná a.s. - Interné oddelenie
🇸🇰Malacky, Slovakia
Penta Hospitals | Rimavska Sobota Hospital - Internal Medicine Department
🇸🇰Rimavská Sobota, Slovakia
Hospital Universitario de Navarra- Medicina Interna
🇪🇸Pamplona, Spain
Ankara Bilkent Sehir Hastanesi
🇹🇷Bilkent Ankara, Turkey
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
🇹🇷Istanbul, Turkey
ASST dei Sette Laghi | Ospedale Di Circolo e Fondazione Macchi Di Varese - Centro Trombosi ed Emostasi
🇮🇹Varese, Italy
Maastricht University Medical Center | School for Cardiovascular Diseases - Biochemie
🇳🇱Maastricht, Netherlands
Izmir Sehir Hastanesi
🇹🇷Izmir, Turkey
Azienda Ospedale-Università di Padova - Medicina Generale ad indirizzo trombotico-emorragico
🇮🇹Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Malattie Emorragiche e Trombotiche
🇮🇹Roma, Italy
Albert Schweitzer Hospital | Internal Medicine - Hematology Department
🇳🇱Dordrecht, Netherlands
Penta Hospitals | Nemocnica Bory - Department of Internal Medicine
🇸🇰Bratislava, Slovakia
Hospitale, s.r.o. - Interné oddelenie
🇸🇰Šahy, Slovakia
Hospital Universitario Infanta Sofia-Medicina Interna
🇪🇸San Sebastian de los Reyes, Madrid, Spain
Hospital Universitari De Girona Doctor Josep Trueta-Medicina Interna
🇪🇸Girona, Spain
Bagcilar Egitim ve Arastirma Hastanesi
🇹🇷Istanbul, Turkey
Erciyes Universitesi Tip Fakultesi
🇹🇷Kayseri, Turkey
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
AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Pronto Soccorso
🇮🇹Treviso, Italy
Zuyderland Medical Centre | Internal Medicine Department
🇳🇱Geleen, Netherlands
Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)
🇳🇱Leiden, Netherlands
Stredoslovenský ústav srdcových a cievnych chorôb, a.s. - Oddelenie angiológie
🇸🇰Banská Bystrica, Slovakia
Saglik Bilimleri Üniversitesi Dr. Siyami Ersek Gögüs Kalp ve Damar Cerrahisi Egitim Ve Arastirma Hastanesi
🇹🇷Istanbul, Turkey
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospit
🇹🇷Istanbul, Turkey
II. interni klinika, Cevni ambulance (angiologicka ambulance), Fakultni nemocnice u sv. Anny v Brne
🇨🇿Brno, Czechia
MHAT National Heart Hospital EAD
🇧🇬Sofia, Bulgaria
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
🇧🇪Gent, Belgium
AZ Groeninge - Campus Kennedylaan
🇧🇪Kortrijk, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium
McGill University Health Centre - Glen Site
🇨🇦Montreal, Quebec, Canada
Hamilton Health Sciences - Hamilton General Hospital (HGH)
🇨🇦Hamilton, Canada
Interni oddeleni, Krnovska nemocnice, Sdruzene zdravotnicke zarizeni Krnov, prispevkova organizace
🇨🇿Krnov, Czechia
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
🇧🇬Ruse, Bulgaria
Specialized Hospital For Active Cardiology Treatment Medica Kor EAD
🇧🇬Ruse, Bulgaria
Medical Institute Ministry of Interior
🇧🇬Sofia, Bulgaria
Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Cardiology Department
🇧🇬Veliko Tarnovo, Bulgaria
University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD
🇧🇬Sofia, Bulgaria
Niagara Health - St. Catharines Site
🇨🇦St. Catharines, Ontario, Canada
Nemocnice Mlada Boleslav - interni oddeleni
🇨🇿Mlada Boleslav, Czechia
Kardiologicka klinika, Fakultni nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czechia
II. interni klinika - klinika kardiologie a angiologie 1. lekarske fakulty a Vseobecne fakultni nemocnice
🇨🇿Praha 2, Czechia
Oddeleni standardni kardiologie, Nemocnice Na Homolce
🇨🇿Praha 5, Czechia
Nemocnice Roudnice nad Labem - interni oddeleni
🇨🇿Roudnice nad Labem, Czechia
University Multiprofile Hospital For Active Treatment 'Sveta Ekaterina' EAD
🇧🇬Sofia, Bulgaria
Kardiologicka a interni ambulance - Ostrava
🇨🇿Ostrava, Czechia
Vojenska nemocnice Brno - kardiologicke interni oddeleni
🇨🇿Brno, Czechia
Krajská zdravotní, Masarykova nemocnice Ústí nad Labem - Kardiologická jednotka intenzivní péce
🇨🇿Usti nad Labem, Czechia
Interni a kardiologicka ambulance, Nemocnice Znojmo, prispevkova organizace
🇨🇿Znojmo, Czechia
Groupe Hospitalier Sud - Amiens
🇫🇷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
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Europeen Georges-Pompidou (HEGP)
🇫🇷Paris, France
CHU Rennes, H Pontchaillou, Cardiologie
🇫🇷Rennes, France
Franziskus-Krankenhaus Berlin | Klinik für Innere Medizin
🇩🇪Berlin, 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
🇩🇪Muenchen, Germany
General Hospital Of Athens G Gennimatas- Department of Vascular Surgery
🇬🇷Athens, Greece
Kistarcsai Flor Ferenc Korház - II. Belgyógyászat - Angiológia
🇭🇺Kistarcsa, Hungary
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ - Belgyógyászati Klinika
🇭🇺Szeged, Hungary
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
🇫🇷Toulouse, France
UNIVERSITAETSKLINIKUM FREIBURG - Universitaets-Herzzentrum Bad Krozingen | Klinik für Kardiologie und Angiologie
🇩🇪Bad Krozingen, Germany
Borsod-Abauj-Zemplen Varmegyei Korhaz es Egyetemi Oktatokorhaz - Kardiovaszkularis es Belgyogyaszati centrum
🇭🇺Miskolc, Hungary
Charité Universitaetsmedizin Berlin - Campus Benjamin Franklin | Med. Klinik fuer Kardiologie, Angiologie und Intensivmedizin
🇩🇪Berlin, Germany
Universitaetsklinikum Hamburg-Eppendorf | II. Medizinische Klinik und Poliklinik | Bereich Haemostaseologie
🇩🇪Hamburg, Germany
University General Hospital Attikon - 1st Department of Vascular surgery University of Athens
🇬🇷Athens, Greece
Semmelweis Egyetem - Belgyógyászati és Hematológiai Klinika, Kardiológia
🇭🇺Budapest, Hungary
Bekes Varmegyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz
🇭🇺Békéscsaba, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont - I. sz. Belgyogyaszati Klinika
🇭🇺Pecs, Hungary
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Zentrum fuer Kardiologie - Kardiologie III | Angiologie
🇩🇪Mainz, Germany
General Hospital Of Thessaloniki Papageorgiou- 1st Department of Surgery
🇬🇷Efkarpia, Greece
University General Hospital of Larissa - Department of Vascular surgery of University of Thessaly
🇬🇷Larissa, Greece
Universitaetsklinikum Muenster | Klinik fuer Kardiologie I Sektion Angiologie
🇩🇪Muenster, Germany
University General Hospital Of Ioannina- Department of Surgery, Vascular Unit Faculty
🇬🇷Ioannina, Greece
General University Hospital Of Patras- Department of Vascular Surgery
🇬🇷Patras, Greece
Somogy Varmegyei Kaposi Mor Oktato Korhaz - Általános Belgyógyászati Osztály
🇭🇺Kaposvár, Hungary