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Thrombolysis, Symptomatic proximal deep vein thrombosis

A study to learn more about how well BAY3018250 works and how safe it is for people with proximal deep vein thrombosis

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.

Trial summary

Enrollment Goal
255
Trial Dates
January 2024 - October 2025
Phase
Phase 2
Could I Receive a placebo
Yes
Products
BAY3018250
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Azienda Unita Sanitaria Locale di Reggio Emilia | Arcispedale Santa Maria Nuova - Cardiovascular MedicineReggio Emilia, 42122, Italy
Recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Angiologia e Malattie della CoagulazioneBologna, 40138, Italy
Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Malattie Emorragiche e TromboticheRoma, 00168, Italy
Not yet recruiting
ASST dei Sette Laghi | Ospedale Di Circolo e Fondazione Macchi Di Varese - Centro Trombosi ed EmostasiVarese, 21100, Italy
Recruiting
AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Pronto SoccorsoTreviso, 31100, Italy
Recruiting
Azienda Ospedale-Università di Padova - Medicina Generale ad indirizzo trombotico-emorragicoPadova, 35128, Italy
Recruiting
Azienda Unita Locale Socio Sanitaria 2 Marca Trevigiana | Castelfranco Veneto Hospital - Angiologia DepartmentCastelfranco Veneto, <unknown>, Italy
Recruiting
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB HaemostaseologieDresden, 01307, Germany
Not yet recruiting
Charité Universitaetsmedizin Berlin - Campus Benjamin Franklin | Med. Klinik fuer Kardiologie, Angiologie und IntensivmedizinBerlin, 12203, Germany
Withdrawn
Franziskus-Krankenhaus Berlin | Klinik für Innere MedizinBerlin, 10787, Germany
Recruiting
LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV | FB AngiologieMuenchen, 80336, Germany
Withdrawn
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Zentrum fuer Kardiologie - Kardiologie III | AngiologieMainz, 55131, Germany
Withdrawn
Universitaetsklinikum Hamburg-Eppendorf | II. Medizinische Klinik und Poliklinik | Bereich HaemostaseologieHamburg, 20246, Germany
Suspended
Universitaetsklinikum Muenster | Klinik fuer Kardiologie I Sektion AngiologieMuenster, 48149 Münster, Germany
Recruiting
AZ Groeninge - Campus KennedylaanKortrijk, 8500, Belgium
Not yet recruiting
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart TilmanLiege, 4000, Belgium
Recruiting
Katholieke Universiteit Leuven (KU Leuven) - Center for Molecular and Vascular Biology (CMVB)Leuven, 3000, Belgium
Recruiting
UZ GentGENT, 9000, Belgium
Recruiting
Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde AfdelingAntwerp, 2650, Belgium
Recruiting
Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Thoracic Vascular Surgery DepartmentGenk, 3600, Belgium
Recruiting
AZ Sint-MaartenMechelen, 2800, Belgium
Not yet recruiting
McGill University Health Centre – Glen SiteMontreal, H4A 3J1, Canada
Withdrawn
Hamilton Health Sciences - Hamilton General Hospital (HGH)Hamilton, L8L 2X2, Canada
Withdrawn
Niagara Health - St. Catharines SiteSt. Catharines, L2S 0A9, Canada
Recruiting
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de RangueilToulouse, 31059, France
Recruiting
Hôpital Louis Mourier - Colombes CedexColombes, 92701, France
Recruiting
Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC)Strasbourg, 67091, France
Recruiting
Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale BlancheBrest, 29609, France
Recruiting
Groupe Hospitalier Sud - AmiensAMIENS cedex1, 80054, France
Recruiting
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Europeen Georges-Pompidou (HEGP)Paris, 75908, France
Recruiting
Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel MontpiedClermont Ferrand, 63003, France
Recruiting
Hôpital Sainte MusseToulon, 83100, France
Not yet recruiting
Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert MichallonLa Tronche, 38700, France
Recruiting
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital NordSaint Etienne, 42000, France
Withdrawn
CHU Rennes, H Pontchaillou, CardiologieRennes, 35033, France
Recruiting
Albert Schweitzer Hospital | Internal Medicine - Hematology DepartmentDordrecht, 3318 AT, Netherlands
Withdrawn
IsalaZwolle, 8025AB, Netherlands
Recruiting
Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)Leiden, 2300 RC, Netherlands
Not yet recruiting
Radboud University Medical Center | Afdeling Interne GeneeskundeNijmegen, 6500 HB, Netherlands
Withdrawn
Maastricht University Medical Center | School for Cardiovascular Diseases - BiochemieMaastricht, 6229 HX, Netherlands
Not yet recruiting
Rijnstate | Arnhem - Internal Medicine Department - Vascular ResearchArnhem, 6815 AD, Netherlands
Recruiting
Zuyderland Medical Centre | Internal Medicine DepartmentGeleen, 6162 BG, Netherlands
Recruiting
Humanitas Mirasole S.p.A. - Centro Trombosi e Malattie EmorragicheRozzano, 20089, Italy
Recruiting
Imelda - Vascular Surgery DeptBonheiden, 2820, Belgium
Not yet recruiting
UNIVERSITAETSKLINIKUM FREIBURG - Universitaets-Herzzentrum Bad Krozingen | Klinik für Kardiologie und AngiologieBad Krozingen, 79189, Germany
Withdrawn
Kardiologicka a interni ambulance - OstravaOstrava, 70852, Czech Republic
Not yet recruiting
Nemocnice Mlada Boleslav - interni oddeleniMlada Boleslav, 293 01, Czech Republic
Recruiting
II. interni klinika - klinika kardiologie a angiologie 1. lekarske fakulty a Vseobecne fakultni nemocnicePraha 2, 128 08, Czech Republic
Not yet recruiting
II. interni klinika, Cevni ambulance (angiologicka ambulance), Fakultni nemocnice u sv. Anny v BrneBrno, 602 00, Czech Republic
Withdrawn
Oddeleni standardni kardiologie, Nemocnice Na HomolcePraha 5, 150 30, Czech Republic
Recruiting
Interni oddeleni, Krnovska nemocnice, Sdruzene zdravotnicke zarizeni Krnov, prispevkova organizaceKrnov, 794 01, Czech Republic
Recruiting
Kardiologicka klinika, Fakultni nemocnice Kralovske VinohradyPraha 10, 100 34, Czech Republic
Not yet recruiting
Interni a kardiologicka ambulance, Nemocnice Znojmo, prispevkova organizaceZnojmo, 669 02, Czech Republic
Not yet recruiting
Nemocnice Roudnice nad Labem - interni oddeleniRoudnice nad Labem, 41301, Czech Republic
Withdrawn
Stredoslovenský ústav srdcových a cievnych chorôb, a.s. - Oddelenie angiológieBanská Bystrica, 974 01, Slovakia
Recruiting
Hospitale, s.r.o. - Interné oddelenieŠahy, 936 01, Slovakia
Not yet recruiting
Penta Hospitals | Hospital and Polyclinic Spisska Nova Ves - Internal Medicine DepartmentSpišská Nová Ves, 052 01, Slovakia
Recruiting
Kardiocentrum AGEL a.s. - Angiologické oddelenieKošice, 040 15, Slovakia
Recruiting
Penta Hospitals | Zeleznicna Nemocnica Kosice - Angiologicka ambulanciaKošice, 040 01, Slovakia
Recruiting
Nemocnicná a.s. - Interné oddelenieMalacky, 901 22, Slovakia
Not yet recruiting
Penta Hospitals | Rimavska Sobota Hospital - Internal Medicine DepartmentRimavská Sobota, 979 01, Slovakia
Not yet recruiting
Hospital Universitario de Navarra- Medicina InternaPamplona, 31008, Spain
Not yet recruiting
Hospital Universitario Infanta Sofia-Medicina InternaSan Sebastian de los Reyes, 28702, Spain
Not yet recruiting
Hospital Universitario la Paz-Medicina InternaMadrid, 28046, Spain
Recruiting
Hospital Universitari De Girona Doctor Josep Trueta-Medicina InternaGirona, 17007, Spain
Suspended
Krajská zdravotní, Masarykova nemocnice Ústí nad Labem - Kardiologická jednotka intenzivní péceUsti nad Labem, 400 11, Czech Republic
Recruiting
Vojenska nemocnice Brno - kardiologicke interni oddeleniBrno, 615 00, Czech Republic
Not yet recruiting
MHAT National Heart Hospital EADSofia, 1309, Bulgaria
Not yet recruiting
University Multiprofile Hospital For Active Treatment 'Alexandrovska' EADSofia, 1431, Bulgaria
Recruiting
University Multiprofile Hospital For Active Treatment 'Sveta Ekaterina' EADSofia, 1431, Bulgaria
Not yet recruiting
Medical Institute Ministry of InteriorSofia, 1606, Bulgaria
Not yet recruiting
Specialized Hospital For Active Cardiology Treatment Medica Kor EADRuse, 7013, Bulgaria
Recruiting
University Multiprofile Hospital For Active Treatment Kanev ADRuse, 7002, Bulgaria
Recruiting
Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Cardiology DepartmentVeliko Tarnovo, 5000, Bulgaria
Withdrawn
Pecsi Tudomanyegyetem Klinikai Kozpont - I. sz. Belgyogyaszati KlinikaPecs, 7624, Hungary
Not yet recruiting
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz - II. BelgyogyaszatSzékesfehérvár, 8000, Hungary
Withdrawn
Borsod-Abauj-Zemplen Varmegyei Korhaz es Egyetemi Oktatokorhaz - Kardiovaszkularis es Belgyogyaszati centrumMiskolc, 3526, Hungary
Not yet recruiting
Bekes Varmegyei Kozponti Korhaz - Dr. Rethy Pal TagkorhazBékéscsaba, 5600, Hungary
Recruiting
Somogy Varmegyei Kaposi Mor Oktato Korhaz - Általános Belgyógyászati OsztályKaposvár, 7400, Hungary
Recruiting
Kistarcsai Flor Ferenc Korház - II. Belgyógyászat - AngiológiaKistarcsa, 2143, Hungary
Not yet recruiting
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ - Belgyógyászati KlinikaSzeged, 6725, Hungary
Not yet recruiting
Semmelweis Egyetem - Belgyógyászati és Hematológiai Klinika, KardiológiaBudapest, 1088, Hungary
Recruiting
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip FakultesiIstanbul, 34098, Turkey
Not yet recruiting
Ankara Bilkent Sehir HastanesiBilkent ankara, 6800, Turkey
Recruiting
Erciyes Universitesi Tip FakultesiKayseri, 38039, Turkey
Suspended
Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitIstanbul, 34846, Turkey
Recruiting
Saglik Bilimleri Üniversitesi Dr. Siyami Ersek Gögüs Kalp ve Damar Cerrahisi Egitim Ve Arastirma HastanesiIstanbul, 34744, Turkey
Recruiting
Izmir Sehir HastanesiIzmir, 35540, Turkey
Not yet recruiting
Bagcilar Egitim ve Arastirma HastanesiIstanbul, 34200, Turkey
Not yet recruiting
University General Hospital of Larissa - Department of Vascular surgery of University of ThessalyLarissa, 41110, Greece
Not yet recruiting
University General Hospital Attikon - 1st Department of Vascular surgery University of AthensAthens, 124 62, Greece
Not yet recruiting
General Hospital Of Thessaloniki Papageorgiou- 1st Department of SurgeryEfkarpia, 564 29, Greece
Recruiting
University General Hospital Of Ioannina- Department of Surgery, Vascular Unit FacultyIoannina, 455 00, Greece
Not yet recruiting
General Hospital Of Athens G Gennimatas- Department of Vascular SurgeryAthens, 115 27, Greece
Recruiting
General University Hospital Of Patras- Department of Vascular SurgeryPatras, 265 04, Greece
Suspended
Penta Hospitals | Nemocnica Bory - Department of Internal MedicineBratislava, 841 03, Slovakia

Primary Outcome

  • AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound
    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
    date_rangeTime Frame:
    at 6 hours, 24 hours, Day 7, Day 30
  • Number of participants with composite of major and clinically relevant non-major (CRNM) bleeding events (ISTH definition)
    The classify of bleeding events use the International Society on Thrombosis and Haemostasis (ISTH) definitions.
    date_rangeTime Frame:
    up to Day 15

Secondary Outcome

  • Ratio to baseline of clot burden, as assessed by quantitative ultrasound
    date_rangeTime Frame:
    at 6 hours, 24 hours, Day 7, Day 30 and Day 90
  • Change from baseline in leg pain severity
    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).
    date_rangeTime Frame:
    at 6 hours, 24 hours, Day 7, Day 30 and Day 90
  • Change from baseline in PVFS scale
    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.
    date_rangeTime Frame:
    at Day 7, Day 30 and Day 90
  • Number of participants with recurrent venous thromboembolism
    date_rangeTime Frame:
    up to Day 90

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3