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2024-515362-13-00RecruitingPhase 2/3

Apixaban/rivaroxaban Versus Aspirin for primary prevention of thrombo-embolic complications in JAK2V617F-positive myeloproliferative neoplasms

Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Next steps

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
1008 (estimated)
First submitted
4 Jul 2024
Start date
1 Aug 2024
Lead sponsor
Centre Hospitalier Regional Et Universitaire De Brest
EU CT number
2024-515362-13-00
EudraCT number
2020-004652-15

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 1008
  • 44 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Formal indication of treatment with LDA or DOAC (thus precluding randomization)
  • Concomitant use of a strong inhibitor or inducer of CYP3A4 (like Ruxolitinib)

Other illness

  • 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

Lab values

  • Renal insufficiency with creatinine <30 ml/mn on Cockcroft and Gault Formula

Age

  • No appropriate contraception (estrogen contraception or no contraception) in women of childbearing age or breastfeeding woman

Other

  • PS>2 or life expectancy <12 months
  • Inability to give informed consent
  • Patients under curatorship/guardianship
  • Planned pregnancy within 24 months

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (44)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire D'AngersAngersFranceRecruiting
Centre Hospitalier Victor DupouyArgenteuil CedexFranceRecruiting
Centre Hospitalier d'AvignonAvignonFranceRecruiting
Centre Hospitalier de la Cote BasqueBayonneFranceRecruiting
Centre Hospitalier de BéziersBéziersFranceRecruiting
Centre Hospitalier Régional et Universitaire de BrestBrestFranceRecruiting
Hopital Prive SevigneCesson SevigneFranceRecruiting
CHU d'EstaingClermont-FerrandFranceRecruiting
Hôpital Henri Mondor, 1 rue Gustave Eiffel,CréteilFranceRecruiting
Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9FranceRecruiting
Centre Hospitalier Departemental VendeeLa Roche Sur Yon Cedex 9FranceRecruiting
Centre Hospitalier De VersaillesLe Chesnay RocquencourtFranceRecruiting
Groupe Hospitalier Du HavreLe Havre CedexFranceRecruiting
Centre Hospitalier Le MansLe Mans Cedex 9FranceRecruiting
Centre Hospitalier De Libourne Robert BoulinLibourneFranceRecruiting
Centre Hospitalier Et Universitaire De LimogesLimoges Cedex 1FranceRecruiting
Centre Leon BerardLyonFranceRecruiting
Centre Hospitalier Regional De MarseilleMarseille Cedex 05FranceRecruiting
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des SourcesMont-De-Marsan CedexFranceRecruiting
Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5FranceRecruiting
Centre Hospitalier des Pays de MorlaixMorlaixFranceRecruiting
Centre Hospitalier Universitaire de NantesNantesFranceRecruiting
Hôpital Privé du ConfluentNantesFranceRecruiting
Centre Hospitalier Universitaire d'OrléansORLEANSFranceRecruiting
Hopital Saint LouisParisFranceRecruiting
Hopital Cochin Saint Vincent De PaulParisFranceRecruiting
Centre Hospitalier de PerigueuxPérigueuxFranceRecruiting
Centre Hospitalier De PerpignanPerpignan CedexFranceRecruiting
Centre Hospitalier Universitaire de BordeauxPessacFranceRecruiting
Centre Hospitalier Annecy GenevoisPringy CedexFranceRecruiting
Centre Hospitalier Intercommunal De CornouailleQuimper CedexFranceRecruiting
Centre Hospitalier Universitaire de RennesRennesFranceRecruiting
Centre Hospitalier De RochefortRochefort CedexFranceRecruiting
Centre hospitalier de RoubaixRoubaixFranceRecruiting
Centre Henri BecquerelRouen CedexFranceRecruiting
Centre Hospitalier Universitaire De La ReunionSaint-DenisFranceRecruiting
Centre Hospitalier Universitaire de la Réunion - Site SudSaint-Pierre CedexFranceRecruiting
Institut de Cancérologie Lucien NeuwirthSaint-Priest-en-JarezFranceRecruiting
Clinique Sainte AnneStrasbourgFranceRecruiting
Centre Hospitalier Régional Universitaire de ToursToursFranceRecruiting
CHU Nancy - Hôpital BraboisVandoeuvre lès NancyFranceRecruiting
Centre Hospitalier Bretagne AtlantiqueVannesFranceRecruiting
Hopital Paul BrousseVillejuif CedexFranceRecruiting
Médipôle Hôpital Mutualiste VilleurbanneVilleurbanneFranceRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.