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Study identifier: NCT05198960 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Polycythemia Vera · Essential Thrombocythemia · Prefibrotic/Early Primary Myelofibrosis  ·  Sponsor: University Hospital, Brest

PhasePhase 3
Planned participants1308
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Philadelphia-negative myeloproliferative neoplasms (MPN) are frequent and chronic myeloid malignancies including Polycythemia Vera (PV), essential thrombocythemia (ET), Primary Myelofibrosis (PMF) and Prefibrotic myelofibrosis (PreMF). These MPNs are caused by the acquisition of mutations affecting activation/proliferation pathways in hematopoietic stem cells. The principal mutations are JAK2V617F, calreticulin (CALR exon 9) and MPL W515. ET or MFP/PreMF patients who do not carry one of these three mutations are declared as triple-negative (3NEG) cases even if they are real MPN cases. These diseases are at high risk of thrombo-embolic complications and with high morbidity/mortality. This risk varies from 4 to 30% depending on MPN subtype and mutational status. In terms of therapy, all patients with MPNs should also take daily low-dose aspirin (LDA) as first antithrombotic drug, which is particularly efficient to reduce arterial but not venous events. Despite the association of a cytoreductive drug and LDA, thromboses still occur in 5-8% patients/year. All these situations have been explored in biological or clinical assays. All of them could increase the bleeding risk. We should look at different ways to reduce the thrombotic incidence: Direct Oral Anticoagulants (DOAC)? In the general population, in medical or surgical contexts, DOACs have demonstrated their efficiency to prevent or cure most of the venous or arterial thrombotic events. At the present time, DOAC can be …

This description comes directly from the study's public registry record.

Talk to the study team

Jean-Christophe IANOTTO, Pr  ·  +33298223421  ·  jean-christophe.ianotto@chu-brest.fr

Always discuss trial participation with your own doctor first.

Locations (42)

CHU d'AngersAngers, FranceRecruiting
CH d'AnnecyAnnecy, FranceNot Yet Recruiting
CH d'ArgenteuilArgenteuil, FranceNot Yet Recruiting
CH d'AvignonAvignon, FranceRecruiting
CH de la Côte Basque BayonneBayonne, FranceNot Yet Recruiting
CH de BéziersBéziers, FranceNot Yet Recruiting
CHU BordeauxBordeaux, FranceRecruiting
CHU BrestBrest, FranceRecruiting
Hôpital privé Cesson-SévignéCesson-Sévigné, FranceNot Yet Recruiting
CHU de Clermont-FerrandClermont-Ferrand, FranceNot Yet Recruiting
Hôpital Henri Mondor (APHP)Créteil, FranceRecruiting
CHU Grenoble AlpesGrenoble, FranceRecruiting

+ 30 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05198960