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

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

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.

Study Overview

• Status: Completed
• Conditions: Thrombolysis; Symptomatic Proximal Deep Vein Thrombosis
• Intervention / Treatment: Drug: BAY3018250; Drug: Placebo to BAY3018250

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2650
    • Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling
  • Bonheiden, Belgium, 2820
    • Imelda - Vascular Surgery Dept
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Thoracic Vascular Surgery Department
  • Ghent, Belgium, 9000
    • UZ Gent
  • Kortrijk, Belgium, 8500
    • AZ Groeninge - campus kennedylaan
  • Leuven, Belgium, 3000
    • Katholieke Universiteit Leuven (KU Leuven) - Center for Molecular and Vascular Biology (CMVB)
  • Mechelen, Belgium, 2800
    • Az Sint-Maarten
• Bulgaria
  • Rousse, Bulgaria, 7002
    • University Multiprofile Hospital For Active Treatment Kanev AD
  • Rousse, Bulgaria, 7013
    • Specialized Hospital For Active Cardiology Treatment Medica Kor EAD
  • Sofia, Bulgaria, 1606
    • Medical Institute Ministry of Interior
  • Sofia, Bulgaria, 1431
    • University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD
  • Sofia, Bulgaria, 1431
    • University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD, Sofia
  • Veliko Tarnovo, Bulgaria, 5000
    • Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre - Glen Site
• Czechia
  • Brno, Czechia, 615 00
    • Vojenská nemocnice Brno - Interní oddelení, pododbor kardiologie
  • Krnov, Czechia, 794 01
    • Interni oddeleni, Krnovska nemocnice, Sdruzene zdravotnicke zarizeni Krnov, prispevkova organizace
  • Prague, Czechia, 100 34
    • Kardiologicka klinika, Fakultni nemocnice Kralovske Vinohrady
  • Prague, Czechia, 128 08
    • Všeobecná fakultní nemocnice v Praze - II. interní klinika - klinika kardiologie a angiologie, AJIP
  • Roudnice nad Labem, Czechia, 41301
    • Nemocnice Roudnice nad Labem - interni oddeleni
  • Znojmo, Czechia, 669 02
    • Interni a kardiologicka ambulance, Nemocnice Znojmo, prispevkova organizace
• France
  • Amiens Cedex1, France, 80054
    • Centre Hospitalier Universitaire Amiens Picardie Site Sud
  • Brest, France, 29609
    • Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche
  • Clermont-Ferrand, France, 63003
    • Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied
  • Colombes, France, 92701
    • Hôpital Louis Mourier - Colombes Cedex
  • La Tronche, France, 38700
    • Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon
  • Paris, France, 75908
    • AP-HP Hopital Europeen Georges-Pompidou (HEGP) - Service de medecine vasculaire
  • Saint-Etienne, France, 42000
    • Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
  • Strasbourg, France, 67091
    • Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC)
  • Toulon, France, 83100
    • Hôpital Sainte Musse
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil - Service de medecine vasculaire
• Germany
  • Bad Krozingen, Germany, 79189
    • UNIVERSITAETSKLINIKUM FREIBURG - Universitaets-Herzzentrum Bad Krozingen | Klinik für Kardiologie und Angiologie
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
  • München, Germany, 80336
    • LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV | FB Angiologie
  • Münster, Germany, 48149 Münster
    • Universitaetsklinikum Muenster | Klinik fuer Kardiologie I Sektion Angiologie
• Greece
  • Athens, Greece, 115 27
    • General Hospital Of Athens G Gennimatas- Department of Vascular Surgery
  • Athens, Greece, 124 62
    • University General Hospital Attikon - 1st Department of Vascular surgery University of Athens
  • Efkarpia, Greece, 564 29
    • General Hospital Of Thessaloniki Papageorgiou- 1st Department of Surgery
  • Ioannina, Greece, 455 00
    • University General Hospital Of Ioannina- Department of Surgery, Vascular Unit Faculty
  • Pátrai, Greece, 265 04
    • General University Hospital Of Patras- Department of Vascular Surgery
• Hungary
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem - Belgyógyászati és Hematológiai Klinika, Kardiológia
  • Békéscsaba, Hungary, 5600
    • Bekes Varmegyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz
  • Kaposvár, Hungary, 7400
    • Somogy Varmegyei Kaposi Mor Oktato Korhaz - Általános Belgyógyászati Osztály
  • Kistarcsa, Hungary, 2143
    • Kistarcsai Flor Ferenc Korház - II. Belgyógyászat - Angiológia
  • Szeged, Hungary, 6725
    • Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ - Belgyógyászati Klinika
  • Székesfehérvár, Hungary, 8000
    • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz - II. Belgyogyaszat
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Angiologia e Malattie della Coagulazione
  • Castelfranco Veneto, Italy, <unknown>
    • Azienda Unita Locale Socio Sanitaria 2 Marca Trevigiana | Castelfranco Veneto Hospital - Angiologia Department
  • Padua, Italy, 35128
    • Azienda Ospedale-Università di Padova - Medicina Generale ad indirizzo trombotico-emorragico
  • Reggio Emilia, Italy, 42122
    • Azienda Unita Sanitaria Locale di Reggio Emilia | Arcispedale Santa Maria Nuova - Cardiovascular Medicine
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Malattie Emorragiche e Trombotiche
  • Rozzano, Italy, 20089
    • Humanitas Mirasole S.p.A. - Centro Trombosi e Malattie Emorragiche
  • Treviso, Italy, 31100
    • AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Pronto Soccorso
  • Varese, Italy, 21100
    • ASST dei Sette Laghi | Ospedale Di Circolo e Fondazione Macchi Di Varese - Centro Trombosi ed Emostasi
• Netherlands
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweitzer Hospital | Internal Medicine - Hematology Department
  • Geleen, Netherlands, 6162 BG
    • Zuyderland Medical Centre | Internal Medicine Department
  • Leiden, Netherlands, 2300 RC
    • Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)
• Slovakia
  • Košice, Slovakia, 040 01
    • Penta Hospitals | Zeleznicna Nemocnica Kosice - Angiologicka ambulancia
  • Košice, Slovakia, 040 15
    • Kardiocentrum AGEL a.s. - Angiologické oddelenie
  • Malacky, Slovakia, 901 22
    • Nemocnicná a.s. - Interné oddelenie
  • Spišská Nová Ves, Slovakia, 052 01
    • Penta Hospitals | Hospital and Polyclinic Spisska Nova Ves - Internal Medicine Department
  • Šahy, Slovakia, 936 01
    • Hospitale, s.r.o. - Interné oddelenie
• Spain
  • Girona, Spain, 17007
    • Hospital Universitari De Girona Doctor Josep Trueta | Medicina Interna
  • Madrid
    • San Sebastián de los Reyes, Madrid, Spain, 28702
      • Hospital Universitario Infanta Sofia | Medicina Interna
• Turkey (Türkiye)
  • Bilkent Ankara, Turkey (Türkiye), 6800
    • Ankara Bilkent Sehir Hastanesi
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
  • Istanbul, Turkey (Türkiye), 34744
    • Saglik Bilimleri Üniversitesi Dr. Siyami Ersek Gögüs Kalp ve Damar Cerrahisi Egitim Ve Arastirma Hastanesi
  • Izmir, Turkey (Türkiye), 35540
    • Izmir Sehir Hastanesi
  • Kayseri, Turkey (Türkiye), 38039
    • Erciyes Universitesi Tip Fakultesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAY3018250 Dose 1; Participants will receive BAY3018250 Dose 1.	Drug: BAY3018250; Dose 1 or dose 2 of BAY3018250
Experimental: BAY3018250 Dose 2; Participants will receive BAY3018250 Dose 2.	Drug: BAY3018250; Dose 1 or dose 2 of BAY3018250
Placebo Comparator: Placebo to BAY3018250; Participants will receive placebo to BAY3018250.	Drug: Placebo to BAY3018250; Matching placebo to BAY3018250

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	up to Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	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.	at Day 7, Day 30 and Day 90
Number of participants with recurrent venous thromboembolism		up to Day 90

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): October 7, 2025
• Study Completion (Actual): December 2, 2025

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: 22138; 2023-503315-15-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes