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 |
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A newly diagnosed cancer site or progression of the malignant disease after complete or partial remission.
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Initiating a new course of chemotherapy with a minimum intent of 3 months therapy
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A VTE risk stratification score of ≥ 2, according to the scoring method
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Age 18 years old or older
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Provide written informed consent
|
Critètes d'exclusion |
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Lesions or conditions at increased risk of clinically significant bleeding (eg. active peptic ulcer disease)
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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). *
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Diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome**
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Planned stem cell transplant
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Life expectancy less than 6 months
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Acute or chronic renal insufficiency with glomerular filtration rate (GFR) < 30 ml/min calculated by the Cockroft and Gault formula.
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Pregnancy***
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Continuous anticoagulation with vitamin K antagonists, low-molecular-weight heparin (LMWH), or other oral anticoagulants
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Weight < 40 Kg
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Platelet count < 50 x 109/L
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Known allergies to ingredients contained in apixaban
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Use of any contraindicated medications with apixaban
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