Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study
Description
Brief Summary
Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective
randomized open blinded end-point (PROBE) study
Phase
N/AInclusion and Exclusion Criteria
- Consecutive patients with a newly diagnosed, objectively confirmed: symptomatic or unsuspected, proximal lower-limb DVT or symptomatic PE or unsuspected PE in a segmental or more proximal pulmonary artery;
- Any type of cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intracerebral metastasis and acute leukemia);
- Signed and dated informed consent of the patient, available before the start of any specific trial procedure.
- age <18 years;
- ECOG Performance Status III or IV;
- life expectancy of less than 6 months; Related to anticoagulant treatment:
- administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization;
- 3 or more doses of a vitamin K antagonist before randomization;
- thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode;
- indication for anticoagulant treatment for a disease other than the index VTE episode; Related to bleeding risk:
- thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy;
- active bleeding or a high risk of bleeding contraindicating anticoagulant treatment;
- recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery
- hemoglobin level lower than 8 g/dL (5.0 mmol/L) or platelet count <75x10^9/L or history of heparin induced thrombocytopenia;
- creatinine clearance < 30 ml /min based on the Cockcroft Gault equation;
- acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range;
- uncontrolled hypertension (systolic BP> 180 mmHg or diastolic BP > 100 mmHg despite antihypertensive treatment);
- concomitant use of strong inhibitors or inducers of both cytochrome P-450 3A4 and P-Glycoprotein; Standard criteria:
- bacterial endocarditis;
- hypersensitivity to the active substance or to any of the excipients of study drug;
- patients participation in other pharmaco therapeutic program with an experimental therapy that is known to effect the coagulation system;
- childbearing potential without proper contraceptive measures, pregnancy, or breast feeding;
- any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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