Apixaban in Preventing Secondary Cancer Related Venous Thrombosis in Cancer Patients Who Have Com… (NCT03080883) | Clinical Trial Compass
CompletedPhase 3
Apixaban in Preventing Secondary Cancer Related Venous Thrombosis in Cancer Patients Who Have Completed Anticoagulation Therapy
United States370 participantsStarted 2017-07-14
Plain-language summary
This randomized phase III trial studies the best dose of apixaban and how well it works in preventing secondary cancer related venous thrombosis in cancer patients who have completed anticoagulation therapy. Apixaban may help in prevention by blocking some of the enzymes needed for venous thrombosis.
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:
* Confirmed acute index (original venous thrombotic) event: lower extremity or upper extremity (jugular, innominate, subclavian, axillary, brachial) DVT, PE, splanchnic (hepatic, portal, splenic, mesenteric, renal, gonadal), or cerebral vein thrombosis for which the patient has received \>= 180 days (but =\< 365 days) of anticoagulant therapy prior to registration; the date, imaging modality, and location of index event will be required; the date of initiation and specific type of anticoagulants used will also be required
* Active cancer defined as metastatic disease and/or any evidence of cancer on cross-sectional or positron emission tomography (PET) imaging, cancer related surgery, chemotherapy or radiation therapy within the past 6 months; Note: non-melanoma skin cancer does not meet the cancer requirement
* Life expectancy \>= 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
* Hemoglobin \>= 8 g/dL obtained =\< 30 days prior to registration
* Platelet count \>= 50,000/mm\^3 obtained =\< 30 days prior to registration
* Alanine aminotransferase (ALT) or aspartate transaminase (AST) =\< 3 x upper limit of normal (ULN) obtained =\< 30 days prior to registration
* Calculated creatinine clearance must be \>= 30 ml/min using the Cockcroft-Gault formula obtained =\< 30 days prior to registration
* Negative serum or urine pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only;
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What they're measuring
1
CIF of Major or Clinically Relevant Non-major Bleeding Combined With Death as Competing Risk
Timeframe: 12 months
Trial details
NCT IDNCT03080883
SponsorAcademic and Community Cancer Research United