Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies
Recruiting · NCT07270263 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of Gdansk
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study investigates the efficacy and safety of direct oral anticoagulants (DOACs) in comparison with standard low-molecular-weight heparin (LMWH) for the prevention of venous thromboembolism in patients with hematological malignancies. Eligible participants will be randomized to receive reduced-dose apixaban, reduced-dose rivaroxaban, or standard-dose LMWH. The primary objective is to evaluate the incidence of venous thromboembolism during a 6-month follow-up period. Secondary objectives include assessment of bleeding complications, overall survival, and treatment adherence. The results of this study may provide evidence for safer and more convenient thromboprophylaxis strategies in patients with blood cancers.
Who can take part
Inclusion criteria
- Active hematologic malignancy at the time of initiation of systemic therapy, including multiple myeloma, myeloproliferative neoplasm, lymphoma or other hematologic cancer with a Khorana score ≥ 2 points (intermediate or high risk of venous thromboembolism, VTE)
- Use of anticoagulant agents for primary thromboprophylaxis, including direct oral anticoagulants (DOACs) at reduced doses (apixaban 2.5 mg twice daily or rivaroxaban 10 mg once daily) or low-molecular-weight heparin (LMWH) (enoxaparin 40 mg subcutaneously once daily).
Exclusion criteria
- Major bleeding within the last month (including gastrointestinal or intracranial bleeding).
- Active major bleeding.
- Hemoglobin concentration \< 8 g/dL.
- Thrombocytopenia with platelet count \<30 × 10⁹/L.
- ECOG performance status of 3 or 4.
- Expected survival \<6 months.
- History of mechanical heart valve or severe mitral stenosis.
- Estimated glomerular filtration rate (eGFR) \< 25 mL/min.
- Hepatic impairment (ALT ≥ 3× upper limit of normal or bilirubin ≥ 2× upper limit of normal).
- Acute coronary syndrome or ischemic stroke within the last 6 months.
- Anticipated significant drug-drug interactions between DOACs and anticancer agents.
- Known antiphospholipid syndrome (APS).
Where it is running
1 location listed.
- Department of Haematology & Transplantology - Gdansk, Pomeranian Voivodeship, Poland