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Evaluating BAY3018250 for treating proximal deep vein thrombosis

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

Phase 2 Interventional Bayer · NCT06149520

This study tests if a new drug called BAY3018250 can safely help dissolve blood clots in people with recent symptoms of proximal deep vein thrombosis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment255 (estimated)
Ages18 Years and up
SexAll
SponsorBayer Industry-sponsored
Locations96 sites (Antwerp and 95 other locations)
Trial IDNCT06149520 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness and safety of BAY3018250, a drug designed to dissolve blood clots, in patients with acute symptomatic proximal deep vein thrombosis (DVT). Participants will receive either BAY3018250 or a placebo while being treated with anticoagulants. The study focuses on individuals who have experienced DVT symptoms for 14 days or less and have specific vein involvement. Researchers will compare outcomes between the two groups to determine the drug's efficacy in resolving blood clots.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with acute symptomatic proximal DVT documented by ultrasound.

Not a fit: Patients with acute pulmonary embolism or those at high risk for bleeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a faster and more effective way to dissolve blood clots in patients with proximal DVT.

How similar studies have performed: While there have been studies on thrombolytic therapies, the specific use of BAY3018250 in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Antwerp and 95 other locations

+46 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ThrombolysisSymptomatic Proximal Deep Vein Thrombosis
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.