Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer (NCT03045406) | Clinical Trial Compass
CompletedPhase 3
Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer
United States1,170 participantsStarted 2017-04-13
Plain-language summary
Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion Criteria:
* 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;
* cre…