NCT07270263Recruiting
Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies
Efficacy and Safety of Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies: A Prospective Randomized Study
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 25 Nov 2025
- Start date
- 22 Nov 2024
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Medical University of Gdansk
- Diseases
- Multiple myeloma
- NCT number
- NCT07270263
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 22 Nov 2024 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticipated significant drug-drug interactions between DOACs and anticancer agents.
Other illness
- Major bleeding within the last month (including gastrointestinal or intracranial bleeding).
- Active major bleeding.
- History of mechanical heart valve or severe mitral stenosis.
- Acute coronary syndrome or ischemic stroke within the last 6 months.
- Known antiphospholipid syndrome (APS).
Lab values
- Hemoglobin concentration \< 8 g/dL.
- Thrombocytopenia with platelet count \<30 × 10⁹/L.
- Estimated glomerular filtration rate (eGFR) \< 25 mL/min.
- Hepatic impairment (ALT ≥ 3× upper limit of normal or bilirubin ≥ 2× upper limit of normal).
Other
- ECOG performance status of 3 or 4.
- Expected survival \<6 months.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Haematology & Transplantology Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.