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Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies

NCT07270263 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-26

No results posted yet for this study

Summary

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.

Conditions

  • Lymphoma
  • Leukemia
  • Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma
  • Venous Thromboembolic Disease
  • VTE (Venous Thromboembolism)
  • PE - Pulmonary Embolism
  • Hematologic Malignacies

Interventions

DRUG

Apixaban

Oral tablet, 2.5 mg twice daily, for at least 6 months.

DRUG

Rivaroxaban

Oral tablet, 10 mg once daily, for at least 6 months.

DRUG

low molecular weight heparin (enoxaparin sodium)

Subcutaneous injection, 40 mg once daily (or equivalent), for at least 6 months.

Sponsors & Collaborators

  • Medical University of Gdansk

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-22
Primary Completion
2026-04-30
Completion
2026-12-31

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07270263 on ClinicalTrials.gov