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ThrombolysisPhase 2SIRIUSNCT06149520

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

A Phase 2 study testing BAY3018250 in people with Thrombolysis and Symptomatic Proximal Deep Vein Thrombosis, run by Bayer at 68 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BAY3018250
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
283 participants
Where
68 sitesin 13 countries
Study dates
15 Jan 2024to 2 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 10Show fewer
  • 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 locations and contacts

68 sites in 13 countries.

68 sites in 13 countries

France10 sites

  • Centre Hospitalier Universitaire Amiens Picardie Site Sud

    Amiens Cedex1, 80054

  • Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche

    Brest, 29609

  • Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied

    Clermont-Ferrand, 63003

  • Hôpital Louis Mourier - Colombes Cedex

    Colombes, 92701

  • Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon

    La Tronche, 38700

  • AP-HP Hopital Europeen Georges-Pompidou (HEGP) - Service de medecine vasculaire

    Paris, 75908

  • Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

    Saint-Etienne, 42000

  • Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC)

    Strasbourg, 67091

  • Hôpital Sainte Musse

    Toulon, 83100

  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil - Service de medecine vasculaire

    Toulouse, 31059

Other trials in France

Italy8 sites

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Angiologia e Malattie della Coagulazione

    Bologna, 40138

  • Azienda Unita Locale Socio Sanitaria 2 Marca Trevigiana | Castelfranco Veneto Hospital - Angiologia Department

    Castelfranco Veneto, <unknown>

  • Azienda Ospedale-Università di Padova - Medicina Generale ad indirizzo trombotico-emorragico

    Padova, 35128

  • Azienda Unita Sanitaria Locale di Reggio Emilia | Arcispedale Santa Maria Nuova - Cardiovascular Medicine

    Reggio Emilia, 42122

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Malattie Emorragiche e Trombotiche

    Roma, 00168

  • Humanitas Mirasole S.p.A. - Centro Trombosi e Malattie Emorragiche

    Rozzano, 20089

  • AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Pronto Soccorso

    Treviso, 31100

  • ASST dei Sette Laghi | Ospedale Di Circolo e Fondazione Macchi Di Varese - Centro Trombosi ed Emostasi

    Varese, 21100

Other trials in Italy

Belgium7 sites

  • Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling

    Antwerp, 2650

  • Imelda - Vascular Surgery Dept

    Bonheiden, 2820

  • Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Thoracic Vascular Surgery Department

    Genk, 3600

  • UZ Gent

    Ghent, 9000

  • AZ Groeninge - Campus Kennedylaan

    Kortrijk, 8500

  • Katholieke Universiteit Leuven (KU Leuven) - Center for Molecular and Vascular Biology (CMVB)

    Leuven, 3000

  • AZ Sint-Maarten

    Mechelen, 2800

Other trials in Belgium

Bulgaria6 sites

  • University Multiprofile Hospital For Active Treatment Kanev AD

    Rousse, 7002

  • Specialized Hospital For Active Cardiology Treatment Medica Kor EAD

    Rousse, 7013

  • University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD, Sofia

    Sofia, 1431

  • Medical Institute Ministry of Interior

    Sofia, 1606

  • Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Czechia6 sites

  • Vojenská nemocnice Brno - Interní oddelení, pododbor kardiologie

    Brno, 615 00

  • Interni oddeleni, Krnovska nemocnice, Sdruzene zdravotnicke zarizeni Krnov, prispevkova organizace

    Krnov, 794 01

  • Kardiologicka klinika, Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Všeobecná fakultní nemocnice v Praze - II. interní klinika - klinika kardiologie a angiologie, AJIP

    Prague, 128 08

  • Nemocnice Roudnice nad Labem - interni oddeleni

    Roudnice nad Labem, 41301

  • Interni a kardiologicka ambulance, Nemocnice Znojmo, prispevkova organizace

    Znojmo, 669 02

Other trials in Czechia

Hungary6 sites

  • Bekes Varmegyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz

    Békéscsaba, 5600

  • Semmelweis Egyetem - Belgyógyászati és Hematológiai Klinika, Kardiológia

    Budapest, 1088

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz - Általános Belgyógyászati Osztály

    Kaposvár, 7400

  • Kistarcsai Flor Ferenc Korház - II. Belgyógyászat - Angiológia

    Kistarcsa, 2143

  • Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ - Belgyógyászati Klinika

    Szeged, 6725

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz - II. Belgyogyaszat

    Székesfehérvár, 8000

Other trials in Hungary

Greece5 sites

  • General Hospital Of Athens G Gennimatas- Department of Vascular Surgery

    Athens, 115 27

  • University General Hospital Attikon - 1st Department of Vascular surgery University of Athens

    Athens, 124 62

  • General Hospital Of Thessaloniki Papageorgiou- 1st Department of Surgery

    Efkarpia, 564 29

  • University General Hospital Of Ioannina- Department of Surgery, Vascular Unit Faculty

    Ioannina, 455 00

  • General University Hospital Of Patras- Department of Vascular Surgery

    Pátrai, 265 04

Other trials in Greece

Slovakia5 sites

  • Penta Hospitals | Zeleznicna Nemocnica Kosice - Angiologicka ambulancia

    Košice, 040 01

  • Kardiocentrum AGEL a.s. - Angiologické oddelenie

    Košice, 040 15

  • Nemocnicná a.s. - Interné oddelenie

    Malacky, 901 22

  • Hospitale, s.r.o. - Interné oddelenie

    Šahy, 936 01

  • Penta Hospitals | Hospital and Polyclinic Spisska Nova Ves - Internal Medicine Department

    Spišská Nová Ves, 052 01

Other trials in Slovakia

Turkey (Türkiye)5 sites

  • Ankara Bilkent Sehir Hastanesi

    Bilkent Ankara, 6800

  • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Saglik Bilimleri Üniversitesi Dr. Siyami Ersek Gögüs Kalp ve Damar Cerrahisi Egitim Ve Arastirma Hastanesi

    Istanbul, 34744

  • Izmir Sehir Hastanesi

    Izmir, 35540

  • Erciyes Universitesi Tip Fakultesi

    Kayseri, 38039

Other trials in Turkey (Türkiye)

Germany4 sites

  • UNIVERSITAETSKLINIKUM FREIBURG - Universitaets-Herzzentrum Bad Krozingen | Klinik für Kardiologie und Angiologie

    Bad Krozingen, 79189

  • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie

    Dresden, 01307

  • LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV | FB Angiologie

    München, 80336

  • Universitaetsklinikum Muenster | Klinik fuer Kardiologie I Sektion Angiologie

    Münster, 48149 Münster

Other trials in Germany

Netherlands3 sites

  • Albert Schweitzer Hospital | Internal Medicine - Hematology Department

    Dordrecht, 3318 AT

  • Zuyderland Medical Centre | Internal Medicine Department

    Geleen, 6162 BG

  • Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)

    Leiden, 2300 RC

Other trials in Netherlands

Spain2 sites

  • Hospital Universitari De Girona Doctor Josep Trueta | Medicina Interna

    Girona, Girona, 17007

  • Hospital Universitario Infanta Sofia | Medicina Interna

    San Sebastián de los Reyes, Madrid, 28702

Other trials in Spain

Canada1 site

  • McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

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

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.

Read more

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.

Being tested
BAY3018250, Placebo to BAY3018250

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY3018250Drug

    Dose 1 or dose 2 of BAY3018250

  • Placebo to BAY3018250Drug

    Matching placebo to BAY3018250

Study groups in NCT06149520
Study groupRoleWhat they receive
BAY3018250 Dose 1ExperimentalParticipants will receive BAY3018250 Dose 1.
Receives: Drug: BAY3018250
BAY3018250 Dose 2ExperimentalParticipants will receive BAY3018250 Dose 2.
Receives: Drug: BAY3018250
Placebo to BAY3018250Placebo comparatorParticipants will receive placebo to BAY3018250.
Receives: Drug: Placebo to BAY3018250

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: at 6 hours, 24 hours, Day 7, Day 30

  2. 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.

    Measured: up to Day 15

Secondary outcomes (4)

  1. Ratio to baseline of clot burden, as assessed by quantitative ultrasound

    Measured: at 6 hours, 24 hours, Day 7, Day 30 and Day 90

  2. 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).

    Measured: at 6 hours, 24 hours, Day 7, Day 30 and Day 90

  3. 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.

    Measured: at Day 7, Day 30 and Day 90

  4. Number of participants with recurrent venous thromboembolism

    Measured: up to Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2023
  2. Study start15 Jan 2024
  3. Primary completion7 Oct 2025
  4. Study completion2 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
283 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06149520
Sponsor's protocol ID
22138
Other IDs
2023-503315-15-00, 2023
Acronym
SIRIUS
Status last verified
Jul 2026
First submitted
15 Nov 2023
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY3018250 in people with Thrombolysis and Symptomatic Proximal Deep Vein Thrombosis, run by Bayer at 68 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in France, Italy, Belgium, Bulgaria, Czechia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound (time frame: at 6 hours, 24 hours, Day 7, Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06149520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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