2024-518861-90-00Not yet recruitingPhase 4
Thromboprophylaxis with Apixaban during neoadjuvant therapy for muscle-invasive Bladder cancer
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Jul 2026
Brief summary (registry, in English)
To evaluate, in adult patients with planned NAT for MIBC followed by radical treatment, the benefits and harms of thromboprophylaxis with apixaban (oral factor Xa inhibitor) DOAC therapy in addition to standard of care compared with standard of care without anticoagulant therapy. NAT will be administered according to local standard of care and may include, but is not limited to, gemcitabine-cisplatin, dose-dense MVAC, perioperative durvalumab with neoadjuvant gemcitabine-cisplatin, or enfortumab vedotin plus pembrolizumab
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 2 Jun 2026
- Start date
- 1 Sept 2026
- Lead sponsor
- HUS-Yhtymae
- Diseases
- Bladder cancer
- EU CT number
- 2024-518861-90-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 210
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with muscle-invasive bladder cancer who are planned to have chemotherapy or similar drug treatment before surgery to remove the bladder or chemoradiotherapy. Half will take apixaban to prevent blood clots; half will not.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Bladder cancer (muscle-invasive) with planned neoadjuvant systemic therapy before radical cystectomy or chemoradiotherapy
- Earlier treatment
- Must not currently take warfarin, LMWH, another DOAC or double anti-platelet medication
Main reasons for not taking part
- Active bleeding or high risk of serious bleeding, such as recent stomach or intestinal bleeding or bleeding in the skull within the past 6 months
- Pregnant or breast-feeding
- Known thrombophilia or known bleeding disorder
- Severe liver impairment or eGFR <30 mL/min/1.73 m2
- Known allergy to apixaban
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous randomization in this trial
Other illness
- Known active bleeding or high risk of clinically significant bleeding (e.g., recent gastrointestinal bleeding or intracranial hemorrhage within the past 6 months).
- Taking strong inhibitors or inductors of both CYP 3A4 and P-glycoprotein, such as anti-seizure medications (e.g. phenytoin, fosphenytoin, carbamazepine), azole-antimycotics (e.g. ketoconazole, itraconazole), HIV-protease inhibitors (e.g. ritonavir, indinavir) and rifampicin
- Known bleeding disorder
- Known allergy to apixaban
Lab values
- Current anticoagulation with warfarin, LMWH, another DOAC or double anti-platelet medication
- Substantial liver impairment (alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >2 x ULN or total bilirubin ≥ 1.5 x ULN)
- eGFR <30 mL/min/1.73 m2
- Platelet count <100 × 109/L (that is, 100 000 mg/L)
- Hb <90 g/L (that is, <9 g/dL)
Other
- Pregnant or breast-feeding female patients
- Women who have had periods in the last 12 months and who are not using highly reliable contraception: (i) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); ii) progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); iii) intrauterine device (IUD); iv) intrauterine hormone-releasing system (IUS); v) bilateral tubal occlusion; vi) vasectomized partner; and vii) sexual abstinence from heterosexual intercourse during the entire period of risk associated with the study treatments
- Any reason why, in the opinion of the investigator(s), the patient should not participate
- Known thrombophilia
Who the study is looking for
- Age ≥ 18 years
- Planned to receive neoadjuvant systemic therapy prior to radical cystectomy or chemoradiotherapy for bladder cancer
- Ability to provide written informed consent prior to study participation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HUS-Yhtymae | Helsinki | Finland | Not yet recruiting |
| Wellbeing Services County Of Central Finland | Jyvaskyla | Finland | Not yet recruiting |
| Kuopio University Hospital | Kuopio | Finland | Not yet recruiting |
| Oulu University Hospital | Oulu | Finland | Not yet recruiting |
| Tampere University Hospital | Tampere | Finland | Not yet recruiting |
| Turku University Hospital | Turku | Finland | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.