Clinical trial NCT06149520: A Study to Learn More About How Well BAY3018250 Works and How Safe it is for People With Proximal Deep Vein Thrombosis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Thrombolysis
Symptomatic Proximal Deep Vein Thrombosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-11-29
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound
timeFrame: at 6 hours, 24 hours, Day 7, Day 30
measure: Number of participants with composite of major and clinically relevant non-major (CRNM) bleeding events (ISTH definition)
timeFrame: up to Day 15
Secondary outcomes:
measure: Ratio to baseline of clot burden, as assessed by quantitative ultrasound
timeFrame: at 6 hours, 24 hours, Day 7, Day 30 and Day 90
measure: Change from baseline in leg pain severity
timeFrame: at 6 hours, 24 hours, Day 7, Day 30 and Day 90
measure: Change from baseline in PVFS scale
timeFrame: at Day 7, Day 30 and Day 90
measure: Number of participants with recurrent venous thromboembolism
timeFrame: up to Day 90
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling
city: Bonheiden
country: Belgium
facility: Imelda - Vascular Surgery Dept
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Thoracic Vascular Surgery Department
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Campus Kennedylaan
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven (KU Leuven) - Center for Molecular and Vascular Biology (CMVB)
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
city: Ruse
country: Bulgaria
facility: University Multiprofile Hospital For Active Treatment Kanev AD
city: Ruse
country: Bulgaria
facility: Specialized Hospital For Active Cardiology Treatment Medica Kor EAD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment 'National Cardiology Hospital' EAD, Sofia
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD, Sofia
city: Sofia
country: Bulgaria
facility: Medical Institute Ministry of Interior
city: Veliko Tarnovo
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Cardiology Department
city: St. Catharines
country: Canada
facility: Niagara Health - St. Catharines Site
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre - Glen Site
state: Quebec
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Hamilton General Hospital (HGH)
city: Brno
country: Czechia
facility: II. interni klinika, Cevni ambulance (angiologicka ambulance), Fakultni nemocnice u sv. Anny v Brne
city: Brno
country: Czechia
facility: Vojenska nemocnice Brno - kardiologicke interni oddeleni
city: Krnov
country: Czechia
facility: Interni oddeleni, Krnovska nemocnice, Sdruzene zdravotnicke zarizeni Krnov, prispevkova organizace
city: Mlada Boleslav
country: Czechia
facility: Nemocnice Mlada Boleslav - interni oddeleni
city: Ostrava
country: Czechia
facility: Kardiologicka a interni ambulance - Ostrava
city: Praha 10
country: Czechia
facility: Kardiologicka klinika, Fakultni nemocnice Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: II. interni klinika - klinika kardiologie a angiologie 1. lekarske fakulty a Vseobecne fakultni nemocnice
city: Praha 5
country: Czechia
facility: Oddeleni standardni kardiologie, Nemocnice Na Homolce
city: Roudnice nad Labem
country: Czechia
facility: Nemocnice Roudnice nad Labem - interni oddeleni
city: Usti nad Labem
country: Czechia
facility: Krajská zdravotní, Masarykova nemocnice Ústí nad Labem - Kardiologická jednotka intenzivní péce
city: Znojmo
country: Czechia
facility: Interni a kardiologicka ambulance, Nemocnice Znojmo, prispevkova organizace
city: AMIENS cedex1
country: France
facility: Groupe Hospitalier Sud - Amiens
city: Brest
country: France
facility: Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche
city: Clermont Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied
city: Colombes
country: France
facility: Hôpital Louis Mourier - Colombes Cedex
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon
city: Paris
country: France
facility: Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Europeen Georges-Pompidou (HEGP)
city: Rennes
country: France
facility: CHU Rennes, H Pontchaillou, Cardiologie
city: Saint Etienne
country: France
facility: Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC)
city: Toulon
country: France
facility: Hôpital Sainte Musse
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil
city: Bad Krozingen
country: Germany
facility: UNIVERSITAETSKLINIKUM FREIBURG - Universitaets-Herzzentrum Bad Krozingen | Klinik für Kardiologie und Angiologie
city: Berlin
country: Germany
facility: Franziskus-Krankenhaus Berlin | Klinik für Innere Medizin
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Benjamin Franklin | Med. Klinik fuer Kardiologie, Angiologie und Intensivmedizin
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf | II. Medizinische Klinik und Poliklinik | Bereich Haemostaseologie
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Zentrum fuer Kardiologie - Kardiologie III | Angiologie
city: Muenchen
country: Germany
facility: LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV | FB Angiologie
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster | Klinik fuer Kardiologie I Sektion Angiologie
city: Athens
country: Greece
facility: General Hospital Of Athens G Gennimatas- Department of Vascular Surgery
city: Athens
country: Greece
facility: University General Hospital Attikon - 1st Department of Vascular surgery University of Athens
city: Efkarpia
country: Greece
facility: General Hospital Of Thessaloniki Papageorgiou- 1st Department of Surgery
city: Ioannina
country: Greece
facility: University General Hospital Of Ioannina- Department of Surgery, Vascular Unit Faculty
city: Larissa
country: Greece
facility: University General Hospital of Larissa - Department of Vascular surgery of University of Thessaly
city: Patras
country: Greece
facility: General University Hospital Of Patras- Department of Vascular Surgery
city: Budapest
country: Hungary
facility: Semmelweis Egyetem - Belgyógyászati és Hematológiai Klinika, Kardiológia
city: Békéscsaba
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz
city: Kaposvár
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz - Általános Belgyógyászati Osztály
city: Kistarcsa
country: Hungary
facility: Kistarcsai Flor Ferenc Korház - II. Belgyógyászat - Angiológia
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Varmegyei Korhaz es Egyetemi Oktatokorhaz - Kardiovaszkularis es Belgyogyaszati centrum
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont - I. sz. Belgyogyaszati Klinika
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ - Belgyógyászati Klinika
city: Székesfehérvár
country: Hungary
facility: Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz - II. Belgyogyaszat
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Angiologia e Malattie della Coagulazione
city: Castelfranco Veneto
country: Italy
facility: Azienda Unita Locale Socio Sanitaria 2 Marca Trevigiana | Castelfranco Veneto Hospital - Angiologia Department
city: Padova
country: Italy
facility: Azienda Ospedale-Università di Padova - Medicina Generale ad indirizzo trombotico-emorragico
city: Reggio Emilia
country: Italy
facility: Azienda Unita Sanitaria Locale di Reggio Emilia | Arcispedale Santa Maria Nuova - Cardiovascular Medicine
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Malattie Emorragiche e Trombotiche
city: Rozzano
country: Italy
facility: Humanitas Mirasole S.p.A. - Centro Trombosi e Malattie Emorragiche
city: Treviso
country: Italy
facility: AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Pronto Soccorso
city: Varese
country: Italy
facility: ASST dei Sette Laghi | Ospedale Di Circolo e Fondazione Macchi Di Varese - Centro Trombosi ed Emostasi
city: Arnhem
country: Netherlands
facility: Rijnstate | Arnhem - Internal Medicine Department - Vascular Research
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital | Internal Medicine - Hematology Department
city: Geleen
country: Netherlands
facility: Zuyderland Medical Centre | Internal Medicine Department
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center | School for Cardiovascular Diseases - Biochemie
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center | Afdeling Interne Geneeskunde
city: Zwolle
country: Netherlands
facility: Isala
city: Banská Bystrica
country: Slovakia
facility: Stredoslovenský ústav srdcových a cievnych chorôb, a.s. - Oddelenie angiológie
city: Bratislava
country: Slovakia
facility: Penta Hospitals | Nemocnica Bory - Department of Internal Medicine
city: Košice
country: Slovakia
facility: Penta Hospitals | Zeleznicna Nemocnica Kosice - Angiologicka ambulancia
city: Košice
country: Slovakia
facility: Kardiocentrum AGEL a.s. - Angiologické oddelenie
city: Malacky
country: Slovakia
facility: Nemocnicná a.s. - Interné oddelenie
city: Rimavská Sobota
country: Slovakia
facility: Penta Hospitals | Rimavska Sobota Hospital - Internal Medicine Department
city: Spišská Nová Ves
country: Slovakia
facility: Penta Hospitals | Hospital and Polyclinic Spisska Nova Ves - Internal Medicine Department
city: Šahy
country: Slovakia
facility: Hospitale, s.r.o. - Interné oddelenie
city: San Sebastian de los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofia-Medicina Interna
state: Madrid
city: Girona
country: Spain
facility: Hospital Universitari De Girona Doctor Josep Trueta-Medicina Interna
city: Madrid
country: Spain
facility: Hospital Universitario la Paz-Medicina Interna
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra- Medicina Interna
city: Bilkent Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
city: Istanbul
country: Turkey
facility: Bagcilar Egitim ve Arastirma Hastanesi
city: Istanbul
country: Turkey
facility: Saglik Bilimleri Üniversitesi Dr. Siyami Ersek Gögüs Kalp ve Damar Cerrahisi Egitim Ve Arastirma Hastanesi
city: Istanbul
country: Turkey
facility: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospit
city: Izmir
country: Turkey
facility: Izmir Sehir Hastanesi
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi
Study officials:
References: