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Apixaban for Preventing Blood Clots in Adults Receiving Neoadjuvant Therapy for Muscle‑Invasive Bladder Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

In this study the focus is on patients with muscle‑invasive bladder cancer who are receiving treatment before surgery or radiation, called neoadjuvant therapy. The trial looks at whether adding the blood‑thinning medicine apixaban, an oral factor Xa inhibitor, can reduce the chance of developing venous thromboembolism (a clot that forms in a vein) compared with not giving any extra blood thinner. The usual cancer medicines that may be used before the main treatment include combinations such as gemcitabine‑cisplatin, MVAC, durvalumab with gemcitabine‑cisplatin, or enfortumab vedotin together with pembrolizumab. The main surgical option is a radical cystectomy, while an alternative is chemoradiotherapy.

The purpose of the study is to find out if the addition of the blood thinner provides more benefit than harm in these patients. Participants are randomly assigned to either receive a daily 5 mg dose of apixaban or to receive no extra blood‑thinning medication while they undergo their standard cancer treatment. Throughout the treatment period, patients have regular check‑ups and a special X‑ray picture called a CT scan to look for any clots or serious bleeding. The term major bleeding refers to serious bleeding that may need a blood transfusion, occur in a vital organ, cause a large drop in blood‑protein levels (hemoglobin), or be life‑threatening.

After the neoadjuvant therapy and before the definitive surgery or radiation, patients continue to be monitored for several months to see if clots or serious bleeding occur, and longer‑term follow‑up looks at overall survival and cancer‑specific outcomes.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
After enrollment you are assigned to one of two groups: the apixaban group or the group that does not receive any anticoagulant medication.
Step 2
Baseline assessments
You will undergo initial medical evaluations that may include blood tests, imaging studies, and a review of your medical history to confirm eligibility and to establish a reference point for later comparisons.
Step 3
Start neoadjuvant therapy
You begin the planned neoadjuvant therapy, which is chemotherapy given before the main treatment; the specific drugs (such as gemcitabine‑cisplatin, dose‑dense mvac, or other regimens) are chosen by your treating center.
Step 4
Initiate apixaban (if assigned)
If you are in the apixaban group you start taking apixaban at a dose of 5 mg by mouth each day.
The medication is taken daily from the first day of neoadjuvant therapy and continues until the scheduled computed tomography (ct) scan that is performed after the final dose of neoadjuvant therapy, but before the radical treatment.
Step 5
Regular monitoring visits
Throughout the neoadjuvant therapy period you attend scheduled clinic visits where health care staff check for signs of blood clots, evaluate any bleeding, and may repeat blood tests to monitor safety.
If you experience symptoms such as leg swelling, chest pain, coughing up blood, or unusual bruising, you are instructed to report these promptly.
Step 6
Ct scan after final neoadjuvant dose
Once the last cycle of neoadjuvant therapy is completed, you undergo a ct scan of the abdomen and pelvis.
The scan is used to assess the tumor response and also to look for any objectively confirmed venous thromboembolism (vte), such as deep vein thrombosis or pulmonary embolism.
Step 7
Stop apixaban (if used)
If you have been taking apixaban, you discontinue the medication after the ct scan is finished, unless your doctor advises otherwise.
Step 8
Radical treatment
Following the ct scan you proceed to the planned radical treatment, which may be radical cystectomy (surgical removal of the bladder) or definitive chemoradiotherapy.
Step 9
Post‑treatment follow‑up (up to 6 months)
After the radical treatment you continue to be monitored for up to six months from the date of randomization.
Additional visits may include imaging or blood tests to detect any delayed clotting events or bleeding complications.
Step 10
Long‑term follow‑up
The study records overall survival and cancer‑specific survival for up to five years after randomization; you may be asked to attend periodic follow‑up appointments during this time.

Who can join the trial?

3 criteria

Age 18 years or older – you must be at least 18 years old.
Planned to receive neoadjuvant systemic therapy before radical cystectomy or chemoradiotherapy for bladder cancer – this means you are scheduled to get medication that travels through the whole body before either surgery to remove the bladder (radical cystectomy) or a combined treatment of chemotherapy (cancer‑killing drugs) and radiation therapy (high‑energy rays).
Ability to give written informed consent – you must be able to read, understand, and sign a form that explains the study and your agreement to join.

Who cannot join the trial?

14 criteria

Having active bleeding or a high chance of serious bleeding, such as a recent stomach bleed or a brain bleed (called intracranial hemorrhage) within the past 6 months.
Taking strong medicines that block or speed up certain liver enzymes (CYP 3A4) and a transport protein (P‑glycoprotein), for example some seizure drugs, antifungal drugs, HIV medicines, or the antibiotic rifampicin.
Being pregnant or breast‑feeding.
Being a woman who has had a menstrual period in the last 12 months and is not using a highly reliable birth‑control method, such as combined hormonal pills, progestogen‑only pills/injections/implants, an intrauterine device (IUD) or hormone‑releasing system (IUS), having had tubal ligation, having a partner who has had a vasectomy, or choosing to abstain from heterosexual intercourse during the study period.
Having already been randomly assigned to this trial in the past.
Any reason the doctor believes you should not take part in the study.
Currently taking other blood‑thinning medicines, such as warfarin, low‑molecular‑weight heparin (LMWH), another oral anticoagulant (DOAC), or using two anti‑platelet drugs together.
Having a known tendency to form clots (thrombophilia).
Having a known disorder that makes you bleed easily (bleeding disorder).
Having significant liver problems, defined as liver enzymes (ALT or AST) more than twice the normal upper limit (ULN) or a total bilirubin level at least 1.5 times the normal upper limit.
Having poor kidney function, measured as an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m².
Having a low platelet count (fewer than 100,000 platelets per microliter of blood).
Having low hemoglobin (Hb) under 90 g/L (which is less than 9 g/dL), indicating anemia.
Being allergic to the study drug apixaban.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Helsinki University Central Hospital
Helsinki, Finland
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Kuopio University Hospital
Kuopio, Finland
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Oulu University Hospital
Oulu, Finland

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Investigated drugs

Apixaban
is a pill taken by mouth that helps prevent blood clots. In this study it is given to patients who are receiving treatment before surgery for bladder cancer, to see if it reduces the chance of clot‑related problems while they undergo their cancer therapy.
Gemcitabine‑cisplatin
is a combination of two chemotherapy drugs that are given through an IV. They work together to kill cancer cells and shrink the tumor before the patient has surgery or radiation. This regimen is one of the standard treatments that participants may receive before their main bladder cancer operation.
Dose‑dense MVAC
is a chemotherapy plan that includes methotrexate, vinblastine, doxorubicin, and cisplatin. “Dose‑dense” means the medicines are given more often than usual, which can make the treatment more intense. It is another possible pre‑surgery therapy used to try to control the bladder cancer.
Durvalumab
is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. In the trial it may be added to a chemotherapy regimen such as gemcitabine‑cisplatin, aiming to improve the response before the patient undergoes the definitive bladder cancer treatment.
Enfortumab vedotin
is a targeted therapy that carries a chemotherapy agent directly to cancer cells. It is given by IV and is sometimes combined with other medicines like pembrolizumab to try to shrink the tumor before surgery or radiation.
Pembrolizumab
is an immunotherapy that blocks a protein called PD‑1, allowing the immune system to better fight cancer. It can be used together with other drugs such as enfortumab vedotin as part of the neoadjuvant (pre‑surgery) treatment plan.

Apixaban

What is already known about the treatment

Apixaban - Apixaban is taken as a 5 mg oral tablet once daily. It is an approved prescription drug that is widely used and described in many medical studies as a direct factor Xa inhibitor for preventing blood clots. It is mainly prescribed to prevent and treat venous thromboembolism and to reduce the risk of stroke in people with atrial fibrillation. The medication works by blocking a protein called factor Xa, which stops the clotting process, and it belongs to the class of direct oral anticoagulants.

Investigated diseases

Venous thromboembolism - A condition in which blood clots form in the veins, most often in the deep veins of the legs (deep‑vein thrombosis) and can travel to the lungs (pulmonary embolism). In patients with bladder cancer, the disease may develop more readily because the cancer and its treatments increase clot‑forming tendency. The clot may first cause leg swelling, pain or warmth, and if it moves to the lungs it can cause sudden shortness of breath or chest discomfort. Over time the clot can grow larger or additional clots may appear in other veins.