Actively Recruiting
Efficacy and Safety of Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies: A Prospective Randomized Study
Led by Medical University of Gdansk · Updated on 2025-12-26
100
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of reduced-dose direct oral anticoagulants (DOACs), specifically apixaban and rivaroxaban, compared with standard low-molecular-weight heparin (LMWH) in preventing venous thromboembolism (VTE) in patients with hematologic malignancies such as multiple myeloma and lymphoma. The study addresses the challenge of thromboprophylaxis in this high-risk population, where current daily injections of LMWH may be burdensome and affect treatment adherence. The trial is prospective, randomized, and open-label, focusing on improved and patient-friendly prevention methods. Participants will be randomly assigned to one of three groups: one receiving apixaban 2.5 mg orally twice daily, another receiving rivaroxaban 10 mg orally once daily, and the third receiving standard-dose LMWH via subcutaneous injection once daily. Each treatment will continue for at least six months. The study compares these regimens to assess their impact on VTE occurrence and bleeding risks, with a follow-up period of six months after treatment initiation. During the study, participants will be monitored for the incidence of venous thromboembolism, major and clinically relevant non-major bleeding events, overall survival, and adherence to the prescribed treatment over six months. Researchers will use standard clinical definitions and criteria to evaluate these outcomes. The trial includes regular assessments to ensure safety and collect data on any adverse events, aiming to provide high-quality evidence that could influence future thromboprophylaxis practices in patients with blood cancers.
CONDITIONS
Brief Title
Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with an active hematologic malignancy such as multiple myeloma, myeloproliferative neoplasm, or lymphoma
- Khorana score of 2 points or higher indicating intermediate or high risk of venous thromboembolism
- Receiving anticoagulant treatment for primary thromboprophylaxis with reduced-dose apixaban, reduced-dose rivaroxaban, or standard-dose low-molecular-weight heparin
You will not qualify if you...
- Major bleeding within the last month, including gastrointestinal or intracranial bleeding
- Active major bleeding at the time of screening
- Hemoglobin concentration less than 8 g/dL
- Platelet count below 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 mitral stenosis
- Estimated glomerular filtration rate (eGFR) less than 25 mL/min
- Liver impairment with ALT levels 3 times above normal or bilirubin levels 2 times above normal
- Acute coronary syndrome or ischemic stroke within the last 6 months
- Expected significant drug interactions between DOACs and anticancer treatments
- Known diagnosis of antiphospholipid syndrome (APS)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At least 6 months
Participants receive reduced-dose apixaban, reduced-dose rivaroxaban, or low-molecular-weight heparin to prevent venous thromboembolism.
Daily medication intake with regular follow-up visits
Trial Site Locations
Total: 1 location
1
Department of Haematology & Transplantology
Gdansk, Pomeranian Voivodeship, Poland, 80-152
Actively Recruiting
Research Team
A
Agata Ogłoza-Puchowska, MD
E
Ewa Lewicka, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here