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Thrombolytic Agent

BAY3018250 for Deep Vein Thrombosis (SIRIUS Trial)

Phase 2

Recruiting

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving therapeutic dose anticoagulation with low molecular weight heparins (LMWHs) and/or direct oral anticoagulants (DOACs) according to the respective product labels

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 with adequate visualization of the most proximal end of the thrombus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 hours, 24 hours, day 7, day 30 and day 90

Awards & highlights

SIRIUS Trial Summary

This trial is testing a drug that may dissolve blood clots in people w/ DVT, to see if it's safe & effective. Results will be measured using ultrasound tests & info on adverse events. Participants will be randomly assigned to high/low dose of drug or placebo.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects include bleeding events that require medical attention. All adverse events during the study will be tracked to assess safety related to BAY3018250 compared to the placebo.

SIRIUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I have a blood clot in at least two major veins in my leg.

SIRIUS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 hours, 24 hours, day 7, day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 hours, 24 hours, day 7, day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 hours, 24 hours, day 7, day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound

Number of participants with composite of major and clinically relevant non-major (CRNM) bleeding events (ISTH definition)

Secondary outcome measures

Change from baseline in PVFS scale

Change from baseline in leg pain severity

Number of participants with recurrent venous thromboembolism

+1 more

SIRIUS Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: BAY3018250 Dose 2Experimental Treatment1 Intervention

Participants will receive BAY3018250 Dose 2.

Group II: BAY3018250 Dose 1Experimental Treatment1 Intervention

Participants will receive BAY3018250 Dose 1.

Group III: Placebo to BAY3018250Placebo Group1 Intervention

Participants will receive placebo to BAY3018250.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,240 Previous Clinical Trials

25,332,522 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the opportunity for participation in this clinical trial currently available?

"The information on clinicialtrials.gov indicates that this trial is not currently seeking patients. It was initially posted on December 13th, 2023 and last updated November 28th, 2023. Despite this study's inactivity, there are an additional 155 studies recruiting participants at the moment."

Answered by AI

How widely dispersed are the locations of this trial in North America?

"At present, this research endeavour is conducted in 44 different centres located around the world from Strasbourg to Bonheiden and Kortrijk. It is encouraged that participants select the clinic closest to them so travel demands can be minimized."

Answered by AI

Has the FDA sanctioned BAY3018250 Dose 2 for public use?

"Given its Phase 2 status, the safety of BAY3018250 Dose 2 has been estimated to be a score of two. This indicates that there is some clinical data indicating it's safe, however without efficacy evidence available yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Learn More About How Well BAY3018250 Works and How Safe it is for People With Proximal Deep Vein Thrombosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06149520.