Apixaban/rivaroxaban Versus Aspirin for primary prevention of thrombo-embolic complications in JAK2V617F-positive myeloproliferative neoplasms
Key facts
- Where
- Angers, Argenteuil Cedex, Avignon, Bayonne, Béziers, Brest, Cesson Sevigne, Clermont-Ferrand, Créteil, Grenoble Cedex 9, La Roche Sur Yon Cedex 9, Le Chesnay Rocquencourt, Le Havre Cedex, Le Mans Cedex 9, Libourne, Limoges Cedex 1, Lyon, Marseille Cedex 05, Mont-De-Marsan Cedex, Montpellier Cedex 5, Morlaix, Nantes, ORLEANS, Paris, Périgueux, Perpignan Cedex, Pessac, Pringy Cedex, Quimper Cedex, Rennes, Rochefort Cedex, Roubaix, Rouen Cedex, Saint-Denis, Saint-Pierre Cedex, Saint-Priest-en-Jarez, Strasbourg, Tours, Vandoeuvre lès Nancy, Vannes, Villejuif Cedex és Villeurbanne, FranciaországSee the 44 sites
- Phase
- 2/3. fázis
Where in Franciaország
- Centre Hospitalier Universitaire D'AngersAngers, FranciaországTaking people
- Centre Hospitalier Victor DupouyArgenteuil Cedex, FranciaországTaking people
- Centre Hospitalier d'AvignonAvignon, FranciaországTaking people
- Centre Hospitalier de la Cote BasqueBayonne, FranciaországTaking people
- Centre Hospitalier de BéziersBéziers, FranciaországTaking people
- Centre Hospitalier Régional et Universitaire de BrestBrest, FranciaországTaking people
- Hopital Prive SevigneCesson Sevigne, FranciaországTaking people
- CHU d'EstaingClermont-Ferrand, FranciaországTaking people
- Hôpital Henri Mondor, 1 rue Gustave Eiffel,Créteil, FranciaországTaking people
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranciaországTaking people
- Centre Hospitalier Departemental VendeeLa Roche Sur Yon Cedex 9, FranciaországTaking people
- Centre Hospitalier De VersaillesLe Chesnay Rocquencourt, FranciaországTaking people
- Groupe Hospitalier Du HavreLe Havre Cedex, FranciaországTaking people
- Centre Hospitalier Le MansLe Mans Cedex 9, FranciaországTaking people
- Centre Hospitalier De Libourne Robert BoulinLibourne, FranciaországTaking people
- Centre Hospitalier Et Universitaire De LimogesLimoges Cedex 1, FranciaországTaking people
- Centre Leon BerardLyon, FranciaországTaking people
- Centre Hospitalier Regional De MarseilleMarseille Cedex 05, FranciaországTaking people
- Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des SourcesMont-De-Marsan Cedex, FranciaországTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranciaországTaking people
- Centre Hospitalier des Pays de MorlaixMorlaix, FranciaországTaking people
- Centre Hospitalier Universitaire de NantesNantes, FranciaországTaking people
- Hôpital Privé du ConfluentNantes, FranciaországTaking people
- Centre Hospitalier Universitaire d'OrléansORLEANS, FranciaországTaking people
- Hopital Cochin Saint Vincent De PaulParis, FranciaországTaking people
- Hopital Saint LouisParis, FranciaországTaking people
- Centre Hospitalier de PerigueuxPérigueux, FranciaországTaking people
- Centre Hospitalier De PerpignanPerpignan Cedex, FranciaországTaking people
- Centre Hospitalier Universitaire de BordeauxPessac, FranciaországTaking people
- Centre Hospitalier Annecy GenevoisPringy Cedex, FranciaországTaking people
- Centre Hospitalier Intercommunal De CornouailleQuimper Cedex, FranciaországTaking people
- Centre Hospitalier Universitaire de RennesRennes, FranciaországTaking people
- Centre Hospitalier De RochefortRochefort Cedex, FranciaországTaking people
- Centre hospitalier de RoubaixRoubaix, FranciaországTaking people
- Centre Henri BecquerelRouen Cedex, FranciaországTaking people
- Centre Hospitalier Universitaire De La ReunionSaint-Denis, FranciaországTaking people
- Centre Hospitalier Universitaire de la Réunion - Site SudSaint-Pierre Cedex, FranciaországTaking people
- Institut de Cancérologie Lucien NeuwirthSaint-Priest-en-Jarez, FranciaországTaking people
- Clinique Sainte AnneStrasbourg, FranciaországTaking people
- Centre Hospitalier Régional Universitaire de ToursTours, FranciaországTaking people
- CHU Nancy - Hôpital BraboisVandoeuvre lès Nancy, FranciaországTaking people
- Centre Hospitalier Bretagne AtlantiqueVannes, FranciaországTaking people
- Hopital Paul BrousseVillejuif Cedex, FranciaországTaking people
- Médipôle Hôpital Mutualiste VilleurbanneVilleurbanne, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Regional Et Universitaire De Brest
- Trial code
- EU 2024-515362-13-00
- Record updated
- 2025. július 11.
- Original description
To demonstrate that low-dose DOAC is more effective than LDA in the primary prevention of arterial or venous thrombosis in JAK2V617F-positive high-risk MPN patientsRead full original descriptionShow less
To demonstrate that low-dose DOAC is more effective than LDA in the primary prevention of arterial or venous thrombosis in JAK2V617F-positive high-risk MPN patients
Inclusion: Patients with diagnosis of Polycythemia Vera or Essential Thrombocythemia or Prefibrotic myelofibrosis according to WHO or BSCH criteria (bone marrow biopsy not compulsory); Patients with JAK2V617F mutation (threshold allele burden > 1%); Patients considered as “high-risk” patients: - 1°) based on age (> 60-year-old) - 2°) based on thrombotic history (compatible with antithrombotic randomization) but aged ≥ 18-year-old; Length of time from MPN diagnostic to inclusion will not exceed 12 months.
Exclusion: Formal indication of treatment with LDA or DOAC (thus precluding randomization); Concomitant use of a strong inhibitor or inducer of CYP3A4 (like Ruxolitinib); Contra-indication to aspirin or DOAC due to allergic situation or recent history of major bleeding; Chronic liver disease or chronic hepatitis; Patient considered at high-risk of bleeding: patients with current or recent major or clinically relevant non major bleeding gastrointestinal or cerebral bleedings; Renal insufficiency with creatinine <30 ml/mn on Cockcroft and Gault Formula; No appropriate contraception (estrogen contraception or no contraception) in women of childbearing age or breastfeeding woman; PS>2 or life expectancy <12 months; Inability to give informed consent; Patients under curatorship/guardianship; Planned pregnancy within 24 months.