Thromboprophylaxis with Apixaban during neoadjuvant therapy for muscle-invasive Bladder cancer
Key facts
- Where
- Helsinki, Jyvaskyla, Kuopio, Oulu, Tampere és Turku, FinnországSee the 6 sites
- Phase
- 4. fázis
Where in Finnország
- HUS-YhtymaeHelsinki, FinnországToborzás még nem indult
- Wellbeing Services County Of Central FinlandJyvaskyla, FinnországToborzás még nem indult
- Kuopio University HospitalKuopio, FinnországToborzás még nem indult
- Oulu University HospitalOulu, FinnországToborzás még nem indult
- Tampere University HospitalTampere, FinnországToborzás még nem indult
- Turku University HospitalTurku, FinnországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- HUS-Yhtymae
- Trial code
- EU 2024-518861-90-00
- Record updated
- 2026. július 27.
- Original description
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 pembrolizumabRead full original descriptionShow less
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
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
Inclusion: 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.
Exclusion: Previous randomization in this trial; 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; 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); 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.