Study of Apixaban or Rivaroxaban Compared to Low-Dose Aspirin for Preventing Blood Clots in Adults with JAK2V617F-positive Myeloproliferative Neoplasms

What this Trial Is About

Philadelphia-negative myeloproliferative neoplasms MPNs such as Polycythemia Vera, Essential Thrombocythemia, and Prefibrotic Myelofibrosis are chronic blood cancers caused by mutations affecting blood cell growth. These diseases carry a high risk of blood clots, which can cause serious complications and death. Current treatments include low-dose aspirin, but blood clots still occur in some patients despite therapy. This trial aims to study whether direct oral anticoagulants DOACs, which have shown benefits in other cancer patients, might help prevent blood clots in MPN patients with a specific mutation called JAK2V617F. Participants will be randomly assigned to receive either a direct oral anticoagulanteither Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once dailyor low-dose aspirin 100 mg once daily. The choice of DOAC is up to the investigator. The treatments will be given to high-risk patients for up to 24 months to compare their effects on clot prevention. Throughout the study, participants will be closely monitored for any thrombotic or bleeding events. During the trial, researchers will track the time until any arterial or venous blood clots occur, as well as any major or clinically relevant bleeding events. They will also evaluate survival, adherence to therapy, quality of life, and healthcare costs related to these treatments. Participants will have regular follow-ups over 24 months, including assessments for heart rhythm problems and safety monitoring. This comprehensive approach aims to better understand the benefits and risks of DOACs compared to aspirin in preventing clots in MPN patients.

AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms