Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07270263

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

Led by Medical University of Gdansk · Updated on 2025-12-26

100

Participants Needed

1

Research Sites

109 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Active hematologic malignancy at the start of systemic therapy, including multiple myeloma, myeloproliferative neoplasm, lymphoma, or other hematologic cancers
  • Khorana score of 2 or more, indicating intermediate or high risk of venous thromboembolism
  • Use of anticoagulant drugs for primary prevention of blood clots, including reduced-dose apixaban (2.5 mg twice daily), reduced-dose rivaroxaban (10 mg once daily), or standard low-molecular-weight heparin (enoxaparin 40 mg subcutaneously once daily)
Not Eligible

You will not qualify if you...

  • Major bleeding episode within the past month, including gastrointestinal or brain bleeding
  • Active major bleeding at the time of screening
  • Hemoglobin level below 8 g/dL
  • Platelet count less than 30 x 10⁹/L
  • Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4
  • Expected survival less than 6 months
  • History of mechanical heart valve or severe narrowing of the mitral valve
  • Estimated kidney function (eGFR) below 25 mL/min
  • Significant liver impairment (ALT three times upper limit or bilirubin twice upper limit of normal)
  • Acute coronary syndrome or ischemic stroke within the last 6 months
  • Expected significant drug interactions between anticoagulants and cancer treatments
  • Known antiphospholipid syndrome (APS)

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Haematology & Transplantology

Gdansk, Pomeranian Voivodeship, Poland, 80-152

Actively Recruiting

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Research Team

A

Agata Ogłoza-Puchowska, MD

CONTACT

E

Ewa Lewicka, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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