A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)
This research is investigating a new medication called abelacimab for people who have cancer and have also developed blood clots in their veins, known as venous thromboembolism (VTE). Currently, a common treatment for these clots is a drug called apixaban. This study aims to directly compare abelacimab with apixaban to see which one works better at stopping new blood clots from forming and which causes fewer bleeding problems. The study will carefully follow participants for six months to record any new clots or bleeding issues. This is a crucial step in finding potentially safer and more effective ways to manage blood clots in people living with cancer.
At a glance
What is this study about?
If you have cancer, you might also be at a higher risk of developing blood clots in your veins, a condition called venous thromboembolism (VTE). These clots can be serious.
Doctors currently use medicines like apixaban to help treat these clots and prevent new ones. However, all medications have potential side effects, and some may include bleeding. Researchers are always looking for new and improved treatments that might be more effective or cause fewer unwanted side effects.
This study, called ASTER, is testing a new drug called abelacimab. It's designed to compare abelacimab against the usual treatment, apixaban. The main goal is to find out if abelacimab is better at preventing new blood clots from forming, and just as importantly, if it causes less bleeding than apixaban. This research is important because it could lead to better options for people with cancer who need treatment for blood clots.
Key takeaways
- This study compares a new blood clot medicine (abelacimab) with a standard one (apixaban).
- It's for people with cancer who have developed blood clots in their veins (VTE).
- The main goals are to see which drug prevents new clots better and causes less bleeding.
- Participation involves regular clinic visits and monitoring for six months.
- You won't know which drug you are receiving, to keep the study fair.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.
Beyond these basic requirements, there will be more specific health conditions and medical history that doctors will check to make sure the study is a good fit for you and that it's safe for you to participate. This includes details about your cancer, the type of blood clot you have, and other medical information.
It's important to discuss all your health conditions and any medicines you take with the study team. They will carefully review everything to confirm if you meet all the necessary criteria for taking part.
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 18 years old or older?
- Have you been diagnosed with cancer?
- Have you recently had a blood clot in your veins (VTE)?
- Are you able to attend clinic visits regularly?
What does participation involve?
If you decide to join this study, you would receive either the new drug (abelacimab) or the standard treatment (apixaban). The study is designed so that neither you nor your doctor will know which treatment you are receiving, which helps ensure the results are unbiased. However, the researchers monitoring the study will know.
You would have regular visits to the clinic for check-ups. These visits will involve various assessments, such as blood tests, to monitor your health and how the treatment is working. Doctors will also keep a close eye on any new blood clots or bleeding episodes. The study will last for six months after you start treatment, during which your health and progress will be carefully followed.
Potential risks and benefits
Locations (12)
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- —UnverifiedFrance
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- —UnverifiedAustria
- —UnverifiedNetherlands
Common questions
What is VTE?
VTE stands for venous thromboembolism. This is the medical term for blood clots that form in the veins, often in the legs (deep vein thrombosis) or lungs (pulmonary embolism).
What does 'randomized' mean?
Randomized means that people taking part are put into different treatment groups by chance, like flipping a coin. This helps make the study fair and scientific.
What is a 'Phase 3' study?
Phase 3 is usually the last step before a new drug might be approved. It involves a large number of people to confirm how well the drug works and if it's safe.
Will I know which drug I'm getting?
No, in this study, neither you nor your doctor will know if you're getting abelacimab or apixaban. This is called 'blinded' and helps ensure unbiased results.
How long will I be in the study?
The main part of the study where your progress is followed will last for six months after you start treatment.
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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