(22138) 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
This research study is looking at a new medicine called BAY 3018250 for people who have a type of blood clot called deep vein thrombosis (DVT) in their leg. Specifically, it's for clots that are in the larger, closer-to-the-body veins (proximal DVT) and are causing symptoms. We want to find out if this new medicine is effective at dissolving these blood clots and improving symptoms like leg pain. We're also carefully checking for any potential side effects, particularly bleeding, which can sometimes happen with blood clot medicines. Some participants will receive the new medicine, while others will receive a dummy medicine (placebo) for comparison.
At a glance
What is this study about?
This research study is about finding better ways to treat deep vein thrombosis, or DVT. A DVT is a blood clot that forms in a deep vein, usually in the leg. When these clots are in the larger veins closer to your body and cause symptoms, they can be serious. This study is testing a new medicine called BAY 3018250 to see if it can help break down these clots and make you feel better.
We are particularly interested in how well BAY 3018250 works compared to a 'dummy' medicine (placebo). This helps us understand if the new medicine is truly effective. We'll be closely monitoring clot size using ultrasound scans over several weeks, and also checking how much your leg pain improves. We're also very focused on safety, carefully tracking any side effects, especially bleeding, which can be a concern with medicines that affect blood clotting.
By taking part, you could contribute to developing new and potentially better treatments for DVT, helping not only yourself but also many other people in the future who experience this condition. All information gathered will be kept confidential.
Key takeaways
- This study tests a new medicine for symptomatic deep vein blood clots in the legs.
- It aims to see if the medicine helps break down clots and reduce pain.
- Safety, especially regarding bleeding, is a key focus.
- Participants will receive either the new medicine or a dummy medicine (placebo).
- Ultrasound scans and pain assessments will be used to monitor progress.
- The study lasts about three months.
Who may be eligible?
To join this study, you must be at least 18 years old. We are looking for both men and women who have been diagnosed with a specific type of deep vein thrombosis (DVT).
Specifically, you would need to have symptoms from a DVT in a larger vein in your leg, arm, or shoulder area, and it must have been diagnosed recently (within the last 72 hours). Also, your DVT must not have spread to certain very large, main veins or be in an unusual location. There are also other health conditions or medicines that might mean you can't join, to make sure the study is safe for everyone involved. Your doctor will be able to tell you if you meet all the necessary criteria.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you at least 18 years old?
- Have you recently (within 3 days) been diagnosed with a DVT that is causing symptoms?
- Is your DVT located in a deep vein in your leg, arm, or shoulder area, but not in certain very large main veins?
- Are you able to attend regular clinic visits for scans and checks?
What does participation involve?
If you decide to take part in this study, you might receive the new medicine (BAY 3018250) or a dummy medicine called a placebo. You won't know which one you are getting, and neither will your study doctor. This is standard practice in medical research to get the clearest results. The medicine will be given as a solution, meaning it would likely be administered intravenously (through a drip).
You would have several visits to the clinic for assessments. These visits would include regular ultrasound scans of your leg at 6 hours, 24 hours, 7 days, 30 days, and 90 days after starting treatment, to measure your blood clot. We would also track your leg pain using simple scales and check your overall ability to move and feel well. We would carefully monitor you for any side effects, especially bleeding, during the study period. The total duration of active follow-up for the main measurements would be up to 90 days (about three months).
Potential risks and benefits
Locations (11)
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedNetherlands
- —UnverifiedGreece
- —UnverifiedBulgaria
- —UnverifiedCzechia
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedSlovakia
Common questions
What is DVT?
DVT stands for Deep Vein Thrombosis, which is a blood clot that forms in a deep vein, usually in your leg.
What does 'placebo' mean?
A placebo is a 'dummy' medicine that looks just like the real medicine but contains no active drug. It helps researchers see if the actual medicine is truly working.
Will I know if I'm getting the real medicine?
No, neither you nor your study doctor will know if you are receiving the new medicine or the placebo. This is to ensure fair and accurate results.
What are the main tests in the study?
The main tests will be regular ultrasound scans to check your blood clot size and questionnaires to measure your leg pain and how you are feeling.
How long will I be in the study?
The main follow-up period for the study is about 90 days, or three months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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