Efficacy and Safety of Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies: A Prospective Randomized Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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).

Locations
Other Locations
Poland
Department of Haematology & Transplantology
RECRUITING
Gdansk
Contact Information
Primary
Agata Ogłoza-Puchowska, MD
a.ogloza@gumed.edu.pl
+48 58 584 43 40
Backup
Ewa Lewicka, Professor
ewa.lewicka@gumed.edu.pl
Time Frame
Start Date: 2024-11-22
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 100
Treatments
Experimental: APIXABAN (reduced dose)
Participants receive apixaban 2.5 mg orally twice daily for at least 6 months.
Experimental: RIVAROXABAN (reduced dose)
Participants receive rivaroxaban 10 mg orally once daily for at least 6 months.
Active_comparator: Low-Molecular-Weight Heparin (LMWH)
Participants receive low-molecular-weight heparin, 40 mg subcutaneously once daily for at least 6 months.
Sponsors
Leads: Medical University of Gdansk

This content was sourced from clinicaltrials.gov