Titre Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients: A Randomized Placebo-Controlled, Double-Blind Clinical Trial
Protocole ID AVERT
ClinicalTrials.gov ID NCT02048865
Type(s) de cancer Autre
Phase Phase II
Type étude Support
Médicament Apixaban
Institution CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
   HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
      3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
Ville Montréal
Investigateur(trice) principal(e) Dre Vicky Tagalakis
Coordonnateur(trice) Tina Ngono Djouonang
 514-340-8222 x24673
Statut Fermé
Critètes d'éligibilité
  • A newly diagnosed cancer site or progression of the malignant disease after complete or partial remission.
  • Initiating a new course of chemotherapy with a minimum intent of 3 months therapy
  • A VTE risk stratification score of ≥ 2, according to the scoring method
  • Age 18 years old or older
  • Provide written informed consent
Critètes d'exclusion
  • Lesions or conditions at increased risk of clinically significant bleeding (eg. active peptic ulcer disease)
  • Objectively confirmed substantial liver insufficiency as defined by clinical manifestations of ascites, cirrhosis, encephalopathy and/or jaundice and/or biochemical abnormalities in liver function tests including hypoalbuminemia (< 3.5 gr/dL), elevated levels of total bilirubin (> 25 umol/L), elevated liver transaminases (2 times the upper limit of normal) and/or biochemical diagnosis of biliary tract obstruction (elevated levels of gamma-glutamyl transferase and alkaline phosphatase, 3 times the upper limit of normal). *
  • Diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome**
  • Planned stem cell transplant
  • Life expectancy less than 6 months
  • Acute or chronic renal insufficiency with glomerular filtration rate (GFR) < 30 ml/min calculated by the Cockroft and Gault formula.
  • Pregnancy***
  • Continuous anticoagulation with vitamin K antagonists, low-molecular-weight heparin (LMWH), or other oral anticoagulants
  • Weight < 40 Kg
  • Platelet count < 50 x 109/L
  • Known allergies to ingredients contained in apixaban
  • Use of any contraindicated medications with apixaban