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

Thrombolysis Clinical Trial

— SIRIUS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06149520
• Other study ID #: 22138
• Secondary ID: 2023-503315-15-0
• Status: Recruiting
• Phase: Phase 2
• Start date: January 15, 2024
• Est. completion date: July 3, 2025

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: July 3, 2025
• Est. primary completion date: May 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 2 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)
• 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
• Male participants with women of childbearing potential (WOCBP) partners unwilling to use highly effective contraception from start of study intervention until end of study.

Related Conditions & MeSH terms

• Thrombolysis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• BAY3018250
Dose 1 or dose 2 of BAY3018250
• Placebo to BAY3018250
Matching placebo to BAY3018250

Locations

Country	Name	City	State
Belgium	Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling	Antwerpen
Belgium	Imelda - Vascular Surgery Dept	Bonheiden
Belgium	AZ Sint-Maarten	Duffel
Belgium	Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Thoracic Vascular Surgery Department	Genk
Belgium	UZ Gent	Gent
Belgium	AZ Groeninge - Campus Kennedylaan	Kortrijk
Belgium	Katholieke Universiteit Leuven (KU Leuven) - Center for Molecular and Vascular Biology (CMVB)	Leuven
Belgium	Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman	Liege
Canada	Hamilton Health Sciences - Hamilton General Hospital (HGH)	Hamilton
Canada	McGill University Health Centre - Glen Site	Montreal	Quebec
Canada	Niagara Health - St. Catharines Site	St. Catharines	Ontario
Czechia	Oblastni nemocnice Mlada Boleslav	Mlada Boleslav
Czechia	Kardiologicka a interni ambulance - Ostrava	Ostrava
France	Groupe Hospitalier Sud - Amiens	Amiens
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	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
Germany	UNIVERSITAETSKLINIKUM FREIBURG - Universitaets-Herzzentrum Bad Krozingen | Klinik für Kardiologie und Angiologie	Bad Krozingen
Germany	Charité Universitaetsmedizin Berlin - Campus Benjamin Franklin | Med. Klinik fuer Kardiologie, Angiologie und Intensivmedizin	Berlin
Germany	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	Universitaetsklinikum Hamburg-Eppendorf | II. Medizinische Klinik und Poliklinik - Bereich Haemostaseologie	Hamburg
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Zentrum fuer Kardiologie - Kardiologie III - Angiologie	Mainz
Germany	LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV - FB Angiologie	Muenchen
Germany	Universitaetsklinikum Muenster | Klinik fuer Kardiologie I - Sektion Angiologie	Muenster
Italy	Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi	Bologna
Italy	Azienda Unita Locale Socio Sanitaria 2 Marca Trevigiana | Castelfranco Veneto Hospital - Angiologia Department	Castelfranco Veneto
Italy	Universita degli Studi di Padova - Azienda Ospedaliera di Padova	Padua
Italy	Azienda Unita Sanitaria Locale di Reggio Emilia | Arcispedale Santa Maria Nuova - Cardiovascular Medicine	Reggio Emilia
Italy	Universita Cattolica del Sacro Cuore - Policlinico Universitario "Agostino Gemelli"	Rome
Italy	Gruppo Humanitas - Humanitas Research Hospital - Centro Trombosi	Rozzano
Italy	Azienda Unita Locale Socio Sanitaria (ULSS) 2 Marca trevigiana - Ospedale Treviso	Treviso
Italy	ASST dei Sette Laghi | Ospedale Di Circolo e Fondazione Macchi Di Varese - Centro Trombosi ed Emostasi	Varese
Netherlands	Rijnstate | Arnhem - Internal Medicine Department - Vascular Research	Arnhem
Netherlands	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	Maastricht University Medical Center | School for Cardiovascular Diseases - Biochemie	Maastricht
Netherlands	Radboud University Medical Center | Afdeling Interne Geneeskunde	Nijmegen
Netherlands	Isala	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Belgium,  Canada,  Czechia,  France,  Germany,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Ratio to baseline of clot burden, as assessed by quantitative ultrasound		at 6 hours, 24 hours, Day 7, Day 30 and Day 90
Secondary	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
Secondary	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
Secondary	Number of participants with recurrent venous thromboembolism		up to Day 90