BAY3018250 for Deep Vein Thrombosis

(SIRIUS Trial)

Recruiting at 126 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bayer

Must be taking: Low molecular weight heparins, DOACs

Must not be taking: Antiplatelet therapy, Antifibrinolytics

Disqualifiers: Pulmonary embolism, Active bleeding, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

255 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, BAY3018250, to determine its effectiveness in dissolving blood clots in individuals with deep vein thrombosis (DVT) in the legs. DVT can cause pain and swelling and poses a serious risk as clots may travel to the lungs. Participants will receive either a high dose, a low dose of the drug, or a placebo (a pill with no medicine) to compare effectiveness and safety. Ideal candidates for this trial have experienced symptoms of proximal DVT for less than 14 days and are already on certain blood thinners. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires participants to be on certain blood thinners (low molecular weight heparins or direct oral anticoagulants) before joining. However, you cannot use antiplatelet therapy (except low-dose aspirin), antifibrinolytic drugs, or therapeutic antibodies during the study.

Is there any evidence suggesting that BAY3018250 is likely to be safe for humans?

Research shows that BAY3018250 is being tested for its ability to break down blood clots in people with deep vein thrombosis (DVT). Although detailed safety information is not yet available, its progression to a Phase 2 trial indicates some early evidence of safety for testing in a larger group.

Participants in these trials are closely monitored for any health issues, known as adverse events, that might occur during the study. This includes monitoring for any bleeding that requires medical attention. Regular blood tests and heart checks are conducted to help ensure participant safety.

If BAY3018250 proves effective and safe, it could offer a new treatment option for managing DVT, particularly for those unable to use current blood thinners. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for DVT?

Unlike the standard treatments for deep vein thrombosis, such as anticoagulants like warfarin and direct oral anticoagulants, BAY3018250 offers a novel approach. Researchers are excited because BAY3018250 potentially targets a different pathway in the clotting process, which could lead to fewer side effects and more effective clot resolution. Additionally, the flexibility of dosing, as seen in the trial's experimental arms, might offer tailored treatment options that better suit individual patient needs. This could represent a significant advancement in how we manage blood clots.

What evidence suggests that BAY3018250 might be an effective treatment for deep vein thrombosis?

Research has shown that BAY3018250 is designed to dissolve blood clots, which is crucial for treating deep vein thrombosis (DVT) because clots in deep veins can be dangerous if they move to the lungs. In this trial, participants will receive either BAY3018250 at different doses or a placebo. BAY3018250 targets a specific protein that stabilizes clots, potentially making it a more effective treatment for DVT. Early results suggest that this drug could break down clots faster than traditional blood thinners, which mainly prevent clots from growing. Although more information is needed to confirm these effects, the unique mechanism of BAY3018250 offers hope for those who might not fully benefit from current treatments. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with recent proximal DVT, involving major leg veins, who are on certain blood thinners and weigh between 50-130 kg. It's not for those with pulmonary embolism, active bleeding risks, recent severe cardiovascular events or surgeries, active cancer treatment (except some skin cancers), or on other excluded medications.

Inclusion Criteria

Signed informed consent

I have a recent deep vein clot confirmed by an ultrasound.

I am on blood thinners like LMWHs or DOACs as prescribed.

Exclusion Criteria

I have a recent blood clot in my lungs causing symptoms.

I am not currently experiencing any active bleeding nor am I at high risk for bleeding.

I have not had a stroke, heart attack, brain bleed, or major surgery in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of high dose or low dose of BAY3018250 or placebo

1 day

1 visit (in-person)

Monitoring

Participants are monitored for safety and effectiveness, including blood samples, physical exams, ECG, vital signs, and ultrasound tests

90 days

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BAY3018250

Trial Overview The study tests BAY3018250's effectiveness in dissolving blood clots against a placebo in people with proximal DVT. Participants will be randomly assigned to receive either a high dose, low dose of the drug or a placebo once and monitored through various medical assessments over 90 days.

How Is the Trial Designed?

Group I: BAY3018250 Dose 2 Experimental Treatment 1 Intervention

Participants will receive BAY3018250 Dose 2.

Group II: BAY3018250 Dose 1 Experimental Treatment 1 Intervention

Participants will receive BAY3018250 Dose 1.

Group III: Placebo to BAY3018250 Placebo Group 1 Intervention

Participants will receive placebo to BAY3018250.

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Published Research Related to This Trial

In a study of 621 patients undergoing total knee replacement, the oral factor Xa inhibitor BAY 59-7939 demonstrated potential efficacy in preventing venous thromboembolism (VTE), with 31.7% to 40.4% of patients experiencing the primary efficacy endpoint across different doses, compared to 44.3% in the enoxaparin group.

The safety profile of BAY 59-7939 was acceptable, with major postoperative bleeding increasing with higher doses, but lower doses (2.5-10 mg b.i.d.) showed fewer bleeding events compared to higher doses, indicating a balance between efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BAY 59-7939: an oral, direct factor Xa inhibitor for the prevention of venous thromboembolism in patients after total knee replacement. A phase II dose-ranging study. Turpie, AG., Fisher, WD., Bauer, KA., et al.[2023]

In a randomized controlled trial involving patients with symptomatic isolated distal deep vein thrombosis, rivaroxaban treatment for six weeks was found to be effective, suggesting a shorter treatment duration may be sufficient.

The study compared the efficacy and safety of six weeks versus three months of rivaroxaban treatment, providing important insights into optimizing anticoagulant therapy for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In symptomatic isolated DVT, 12 wk vs. 6 wk of rivaroxaban reduced recurrent VTE at 24 mo. DeLoughery, TG.[2023]

In a study of 387 patients with deep vein thrombosis (DVT), the development of post-thrombotic syndrome (PTS) was found to significantly lower quality of life (QOL) scores over a 2-year period, indicating that PTS is a major factor affecting long-term health outcomes.

Patients who developed PTS experienced less improvement in their QOL compared to those who did not, highlighting the importance of preventing and treating PTS to enhance patient well-being after a DVT diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of health-related quality of life during the 2 years following deep vein thrombosis. Kahn, SR., Shbaklo, H., Lamping, DL., et al.[2023]

In a study of 543 patients with acute deep vein thrombosis, rivaroxaban showed a lower incidence of venous thromboembolic complications (5.4% to 6.6%) compared to standard therapy (9.9%) over 84 days, indicating its efficacy in treating this condition.

Rivaroxaban also demonstrated a favorable safety profile, with major and clinically relevant nonmajor bleeding occurring in 2.2% to 6.0% of patients, compared to 8.8% in those receiving standard therapy, suggesting it may be a safer alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein-DVT Dose-Ranging Study. Buller, HR., Lensing, AW., Prins, MH., et al.[2022]

A systematic review comparing oral direct thrombin inhibitors and oral factor Xa inhibitors to conventional anticoagulants for treating deep vein thrombosis (DVT) was conducted, analyzing multiple studies to assess efficacy and safety.

The review found that both types of newer oral anticoagulants (direct thrombin and factor Xa inhibitors) are effective alternatives to traditional anticoagulants, potentially offering similar or improved outcomes for DVT treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In DVT, oral DTIs and factor Xa inhibitors reduce major bleeding but not recurrent VTE vs. conventional anticoagulants. Benz, AP., Eikelboom, JW.[2023]

In a long-term follow-up of 124 patients with acute deep-vein thrombosis, 42% had died within 6 to 8 years, with higher mortality rates in older patients and those with cancer or stroke, primarily due to cancer or cardiovascular disease.

While recurrent venous thromboembolism was relatively uncommon (15%), 42% of patients reported ongoing symptoms like pain and swelling in the affected leg, which were linked to poorer health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of deep-vein thrombosis. Beyth, RJ., Cohen, AM., Landefeld, CS.[2006]

Bay U3405, a thromboxane A2 receptor antagonist, significantly reduced thrombus formation in a baboon model, showing a 33% decrease in platelet deposition after 2 hours compared to control studies.

The treatment specifically inhibited platelet aggregation in response to collagen without affecting other coagulation tests, indicating its targeted mechanism of action in reducing arterial thrombosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo inhibition of acute platelet-dependent thrombosis in a baboon model by Bay U3405, a thromboxane A2-receptor antagonist. Kotzé, HF., Lamprecht, S., Badenhorst, PN., et al.[2014]

In a study of 200 patients with deep vein thrombosis (DVT), those treated with novel oral anticoagulants (NOACs) like rivaroxaban and apixaban showed a significantly higher rate of blood vessel recanalization compared to those treated with conventional methods (low molecular weight heparin and vitamin K antagonists) after 180 days.

The average free lumen of blood vessels in the NOAC group was 85%, compared to 73% in the conventional treatment group, indicating that NOACs are a more effective option for treating DVT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recanalization rate of proximal deep venous thrombosis related to therapeutic modality during six months follow-up. Begić, A., Begić, E., Dilić, M., et al.[2022]

The JETi8 peripheral thrombectomy system demonstrated a high technical success rate of 76% in treating acute deep vein thrombosis (DVT) in a study of 18 patients, with an impressive mean thrombus reduction of 92%.

The overall procedural success rate was 100%, indicating that the JETi8 system is a safe and effective option for thrombectomy, with only one adverse event reported (a subsegmental pulmonary embolism).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Thrombectomy with the JETi8 Peripheral Thrombectomy System for the Treatment of Deep Vein Thrombosis. Cournoyer-Rodrigue, J., Bui, TB., Gilbert, P., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06149520

NCT06149520 | A Study to Learn More About How Well ... 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 ...

2. clinicaltrials.eu clinicaltrials.eu/inn/bay-3018250/

BAY 3018250: A New Treatment for Deep Vein Thrombosis This article explores the ongoing clinical trial of BAY 3018250, a promising new drug being studied for the treatment of proximal deep vein thrombosis (DVT).

3. ctv.veeva.com ctv.veeva.com/study/a-study-to-learn-more-about-how-well-bay3018250-works-and-how-safe-it-is-for-people-with-proximal-de

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

4. bayer.com bayer.com/en/us/news-stories/phase-ii-study-with-first-in-class-anti-alpha2-antiplasmin-antibody

Bayer initiates Phase II study with first-in-class anti-alpha2 ... Anti-alpha2 antiplasmin antibody is being studied in patients with deep vein thrombosis to assess its potential as a thrombolytic.

5. withpower.com withpower.com/trial/bay3018250-for-deep-vein-thrombosis-d41f7

BAY3018250 for Deep Vein Thrombosis (SIRIUS Trial) 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 ...

6. trialx.com trialx.com/clinical-trials/listings/285492/a-study-to-learn-more-about-how-well-bay3018250-works-and-how-safe-it-is-for-people-with-proximal-deep-vein-thrombosis/?&radius=10&place=Putzu&user_country=Taiwan

A Study to Learn More About How Well BAY3018250 ... 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.

7. fdaaa.trialstracker.net fdaaa.trialstracker.net/trial/NCT06149520/

NCT06149520: An ongoing trial by Bayer Full data ; A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of BAY 3018250 in Patients With ...