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New drug aims to dissolve dangerous blood clots in the leg

NCT ID NCT06149520

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This study tested a drug called BAY 3018250 in 258 people with deep vein thrombosis (DVT), a condition where blood clots form in deep leg veins. The drug is designed to dissolve clots, unlike standard blood thinners that only prevent clots from growing. Researchers compared two doses of BAY 3018250 against a placebo to see how well it reduces clot size and whether it causes bleeding. Participants were monitored for 90 days with ultrasound scans and health checks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BAY 3018250 (a clot-dissolving drug)
What this could lead to
If it works, this could offer a new way to quickly dissolve blood clots in people with deep vein thrombosis, potentially reducing symptoms and complications.
What could go wrong
This is an early Phase 2 trial with only 258 participants, so results may not apply to everyone. The drug may not dissolve clots better than standard care and could increase bleeding risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

283 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Symptomatic proximal deep vein thrombosis Thrombolysis

Contacts and locations

Locations

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

    Paris, 75908, France

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

    Varese, 21100, Italy

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

    Treviso, 31100, Italy

  • AZ Groeninge - Campus Kennedylaan

    Kortrijk, 8500, Belgium

  • AZ Sint-Maarten

    Mechelen, 2800, Belgium

  • Albert Schweitzer Hospital | Internal Medicine - Hematology Department

    Dordrecht, 3318 AT, Netherlands

  • Ankara Bilkent Sehir Hastanesi

    Bilkent Ankara, 6800, Turkey (Türkiye)

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

    Padova, 35128, Italy

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

    Bologna, 40138, Italy

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

    Castelfranco Veneto, <unknown>, Italy

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

    Reggio Emilia, 42122, Italy

  • Bekes Varmegyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz

    Békéscsaba, 5600, Hungary

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

    Brest, 29609, France

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

    Saint-Etienne, 42000, France

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

    Toulouse, 31059, France

  • Centre Hospitalier Universitaire Amiens Picardie Site Sud

    Amiens Cedex1, 80054, France

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

    La Tronche, 38700, France

  • Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied

    Clermont-Ferrand, 63003, France

  • Erciyes Universitesi Tip Fakultesi

    Kayseri, 38039, Turkey (Türkiye)

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

    Székesfehérvár, 8000, Hungary

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

    Roma, 00168, Italy

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

    Athens, 115 27, Greece

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

    Efkarpia, 564 29, Greece

  • General University Hospital Of Patras- Department of Vascular Surgery

    Pátrai, 265 04, Greece

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

    Strasbourg, 67091, France

  • Hospital Universitari De Girona Doctor Josep Trueta | Medicina Interna

    Girona, Girona, 17007, Spain

  • Hospital Universitario Infanta Sofia | Medicina Interna

    San Sebastián de los Reyes, Madrid, 28702, Spain

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

    Šahy, 936 01, Slovakia

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

    Rozzano, 20089, Italy

  • Hôpital Louis Mourier - Colombes Cedex

    Colombes, 92701, France

  • Hôpital Sainte Musse

    Toulon, 83100, France

  • Imelda - Vascular Surgery Dept

    Bonheiden, 2820, Belgium

  • Interni a kardiologicka ambulance, Nemocnice Znojmo, prispevkova organizace

    Znojmo, 669 02, Czechia

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

    Krnov, 794 01, Czechia

  • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

    Istanbul, 34098, Turkey (Türkiye)

  • Izmir Sehir Hastanesi

    Izmir, 35540, Turkey (Türkiye)

  • Kardiocentrum AGEL a.s. - Angiologické oddelenie

    Košice, 040 15, Slovakia

  • Kardiologicka klinika, Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34, Czechia

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

    Leuven, 3000, Belgium

  • Kistarcsai Flor Ferenc Korház - II. Belgyógyászat - Angiológia

    Kistarcsa, 2143, Hungary

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

    München, 80336, Germany

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

    Leiden, 2300 RC, Netherlands

  • McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1, Canada

  • Medical Institute Ministry of Interior

    Sofia, 1606, Bulgaria

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

    Veliko Tarnovo, 5000, Bulgaria

  • Nemocnice Roudnice nad Labem - interni oddeleni

    Roudnice nad Labem, 41301, Czechia

  • Nemocnicná a.s. - Interné oddelenie

    Malacky, 901 22, Slovakia

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

    Spišská Nová Ves, 052 01, Slovakia

  • Penta Hospitals | Zeleznicna Nemocnica Kosice - Angiologicka ambulancia

    Košice, 040 01, Slovakia

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

    Istanbul, 34744, Turkey (Türkiye)

  • Semmelweis Egyetem - Belgyógyászati és Hematológiai Klinika, Kardiológia

    Budapest, 1088, Hungary

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz - Általános Belgyógyászati Osztály

    Kaposvár, 7400, Hungary

  • Specialized Hospital For Active Cardiology Treatment Medica Kor EAD

    Rousse, 7013, Bulgaria

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

    Szeged, 6725, Hungary

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

    Bad Krozingen, 79189, Germany

  • UZ Gent

    Ghent, 9000, Belgium

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

    Dresden, 01307, Germany

  • Universitaetsklinikum Muenster | Klinik fuer Kardiologie I Sektion Angiologie

    Münster, 48149 Münster, Germany

  • Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling

    Antwerp, 2650, Belgium

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

    Athens, 124 62, Greece

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

    Ioannina, 455 00, Greece

  • University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD

    Sofia, 1431, Bulgaria

  • University Multiprofile Hospital For Active Treatment Kanev AD

    Rousse, 7002, Bulgaria

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

    Sofia, 1431, Bulgaria

  • Vojenská nemocnice Brno - Interní oddelení, pododbor kardiologie

    Brno, 615 00, Czechia

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

    Prague, 128 08, Czechia

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

    Genk, 3600, Belgium

  • Zuyderland Medical Centre | Internal Medicine Department

    Geleen, 6162 BG, Netherlands

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