AuthorisedTherapeutic use (Phase IV)Interventional

Thromboprophylaxis with apixaban during neoadjuvant therapy for muscle-invasive bladder cancer (ACB): An international randomized controlled trial evaluating apixaban versus no anticoagulation in patients scheduled to undergo radical cystectomy or chemoradiotherapy for muscle-invasive bladder cancer

People receiving treatment for bladder cancer before major surgery or radiotherapy face a higher risk of developing blood clots in their legs or lungs. These clots can cause pain and serious health problems. This clinical trial is testing whether taking a blood-thinning tablet called apixaban can safely prevent these clots. Participants are split into two groups by chance. One group takes apixaban tablets alongside their pre-surgery cancer therapy, while the other group receives standard care with no preventative blood thinners. Doctors will monitor both groups closely using scans and health checks to compare how many clots occur and watch for any bleeding issues. The study aims to discover whether apixaban protects patients effectively and safely during their cancer treatment.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

HUS-Yhtymae

Enrolment target

210

Start

27 Jul 2026

Venous thromboembolism (in bladder cancer patients)

What is this study about?

Bladder cancer treatment often involves having chemotherapy before a main operation to remove the bladder, or before radiotherapy. This pre-treatment helps shrink the tumour and improve overall results. However, having cancer and going through intensive treatments can make the blood more likely to clot. These clots can form in the deep veins of the legs or travel to the lungs, causing breathlessness, chest pain, and other serious health issues.

Currently, doctors do not routinely give preventative blood-thinning tablets during this initial treatment phase. In this clinical trial, known as the ACB study, doctors want to find out if giving a blood-thinning medication called apixaban can protect patients from these clots. Apixaban is an established, widely used medicine in the NHS for treating and preventing clots in other conditions.

Participants will be placed into one of two groups: one group takes apixaban during their pre-surgery cancer treatment, and the other group receives usual care without blood thinners. Both groups will have regular scans and check-ups so doctors can see if apixaban reduces blood clots, while checking that it does not cause problematic bleeding.

By taking part, patients help doctors learn whether this simple tablet should become a routine part of bladder cancer care in the UK and worldwide, potentially making cancer treatment safer for future patients.

Key takeaways

The study tests whether the blood thinner apixaban safely prevents blood clots in people having treatment for bladder cancer.
Participants are placed at random into either the apixaban group or the standard care group.
Doctors will use routine CT scans and checks to look for clots and monitor for any bleeding.
Study appointments are designed to fit around your usual cancer care schedule.
Joining is completely voluntary, and choosing not to take part will not change your normal NHS treatment.

Who may be eligible?

This trial is open to adults aged 18 and older who have been diagnosed with muscle-invasive bladder cancer. This means the cancer cells have spread into the deeper muscle layer of the bladder wall.

To be suitable, you must be scheduled to receive treatment (such as chemotherapy) before having major surgery to remove the bladder or before having combined chemotherapy and radiotherapy. Both men and women are able to join.

You may not be able to take part if you already take regular blood thinners for another health condition, or if you have a medical issue that puts you at a very high risk of bleeding. Your hospital cancer specialist will review your full medical history to decide whether joining the study is safe for you.

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 aged 18 or over?
Have you been diagnosed with muscle-invasive bladder cancer?
Are you due to have chemotherapy before bladder surgery or chemoradiotherapy?
Are you free from any current conditions causing a high risk of bleeding?
Are you willing to attend regular monitoring appointments and scans?

Answer every question to see your result.

What does participation involve?

If you decide to join, a computer will assign you to one of two groups by chance (randomly). One group will take apixaban tablets by mouth every day during their pre-surgery cancer treatment. The other group will receive usual standard care with no preventative blood thinners. Your study visits and blood tests will usually take place during your normal hospital cancer appointments. Before your planned surgery or radiotherapy, you will have a routine CT scan to look for any hidden blood clots. Doctors will also check on your health and recovery for up to six months after you join the trial.

Potential risks and benefits

Taking part may reduce your chances of developing a serious blood clot, and you will receive extra health checks and monitoring from the study team. However, apixaban is a blood thinner, which means it carries a risk of bleeding, such as bruising easily, nosebleeds, or more rarely, heavier bleeding that needs treatment. There is also a chance you are placed in the group that does not receive the study drug. Taking part is entirely voluntary. You can leave the study at any point without giving a reason, and your standard NHS medical care will continue as normal.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland

Common questions

What is apixaban?

Apixaban is a common prescription tablet that slows down how fast blood clots, helping to stop dangerous blockages from forming in blood vessels.

Why are people with bladder cancer at higher risk of clots?

Cancer itself, along with treatments like chemotherapy and spending more time resting, can make the blood thicker and more prone to clotting.

Can I choose which group I am placed in?

No. A computer assigns you to a group by chance. This makes sure the trial is fair and that the results are reliable.

Will joining the study delay my cancer treatment or surgery?

No. The trial is designed to fit around your existing treatment plan and should not delay your chemotherapy, radiotherapy, or surgery.

What should I do if I notice bleeding while on the trial?

You will be given 24-hour contact numbers for your hospital team. You should contact them straight away so they can advise you and adjust your treatment if needed.