Titre A Phase 2 Pilot Randomized Controlled Trial Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients
Protocole ID AIRPORT-MPN
ClinicalTrials.gov ID NCT04243122
Type(s) de cancer NMP : Vaquez , Thrombocythémie essentielle, Métaplasie myéloide
Phase Phase II
Type étude Clinique
Médicament Apixaban
Institution CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
   HOPITAL FLEURIMONT
      3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
Ville Sherbrooke
Investigateur(trice) principal(e) Dre Dominique Toupin
Coordonnateur(trice) Anick Champoux
 819-346-1110 poste 12811
Statut Fermé
Critètes d'éligibilité
  • Male or female subjects aged 18 years or older,
  • Confirmed diagnosis of PV, JAK2ET or JAK2 pre-fibrotic MF, per local clinical definitions
  • Able and willing to comply with study procedures and follow-up examinations contained within the written consent form
Critètes d'exclusion
  • Known allergy to apixaban or aspirin,
  • Another need for anticoagulation or specific anti-platelet therapy,
  • Contraindication to thromboprophylaxis (which would specifically include but not be limited to platelets less than 50x10^9/L and acquired Von Willebrand disease),
  • Current pregnancy or breast-feeding,
  • Renal dysfunction (Creatine Clearance <25 mL/min),
  • Known liver disease
  • Currently on any medication with a known interaction to apixaban
  • Unwilling to use an effective means of contraception for women of childbearing potential
  • Overtly fibrotic myelofibrosis
  • Myelodysplastic/myeloproliferative neoplasms