Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies
NCT ID: NCT07270263
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-11-22
2026-12-31
Brief Summary
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Detailed Description
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This study is designed as a prospective, randomized, open-label, parallel-group trial to compare the efficacy and safety of reduced-dose apixaban and rivaroxaban with standard-dose LMWH in patients with hematologic malignancies requiring primary thromboprophylaxis.
Approximately 100 patients will be randomized in a 1:1:1 ratio to receive:
Apixaban 2.5 mg orally twice daily, Rivaroxaban 10 mg orally once daily, or LMWH (enoxaparin 40 mg subcutaneously once daily or equivalent). The primary endpoint is the incidence of symptomatic or objectively confirmed VTE within 6 months of randomization. Secondary endpoints include major and clinically relevant non-major bleeding events (as defined by ISTH), treatment adherence, and overall survival at 6 months.
This study aims to address the unmet clinical need for optimized, patient-friendly thromboprophylaxis in hematologic malignancies and to provide high-quality data that may guide future clinical practice.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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APIXABAN (reduced dose)
Participants receive apixaban 2.5 mg orally twice daily for at least 6 months.
Apixaban
Oral tablet, 2.5 mg twice daily, for at least 6 months.
RIVAROXABAN (reduced dose)
Participants receive rivaroxaban 10 mg orally once daily for at least 6 months.
Rivaroxaban
Oral tablet, 10 mg once daily, for at least 6 months.
Low-Molecular-Weight Heparin (LMWH)
Participants receive low-molecular-weight heparin, 40 mg subcutaneously once daily for at least 6 months.
low molecular weight heparin (enoxaparin sodium)
Subcutaneous injection, 40 mg once daily (or equivalent), for at least 6 months.
Interventions
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Apixaban
Oral tablet, 2.5 mg twice daily, for at least 6 months.
Rivaroxaban
Oral tablet, 10 mg once daily, for at least 6 months.
low molecular weight heparin (enoxaparin sodium)
Subcutaneous injection, 40 mg once daily (or equivalent), for at least 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Medical University of Gdansk
OTHER
Responsible Party
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Locations
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Department of Haematology & Transplantology
Gdansk, Pomeranian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Agata Ogłoza-Puchowska, MD, Principle Investigator
Role: primary
Ewa Lewicka, Professor
Role: backup
Other Identifiers
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GUM-HEM-DOAC-2025-01
Identifier Type: -
Identifier Source: org_study_id