Pulmonary Embolism Clinical Trial
Official title:
A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism
This randomized phase III trial studies the side effects of and compares apixaban and
dalteparin in reducing blood clots in patients with cancer-related venous thromboembolism.
Venous thromboembolism is a condition in which a blood clot forms in a vein and then breaks
off and moves through the bloodstream. Patients with cancer are at increased risk for venous
thromboembolism. Apixaban and dalteparin are drugs used to prevent blood clots from forming
or to treat blood clots that have formed. It is not yet known whether apixaban or dalteparin
is more effective in reducing blood clots in patients with cancer related venous
thromboembolism.
ADAM-VTE
PRIMARY OBJECTIVES:
I. Any episode of major bleeding including fatal bleeding.
SECONDARY OBJECTIVES:
I. Venous thromboembolism (VTE) recurrence including deep vein thrombosis (DVT), pulmonary
embolism (PE), fatal PE, or arterial thromboembolism.
II. Any episode of major bleeding including fatal bleeding or any episode of clinically
relevant non-major bleeding.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive apixaban 10 mg orally (PO) twice daily (BID) on days 1-7 and
lower-dose apixaban 5 mg PO BID on days 8-180.
ARM II: Patients receive dalteparin 200 international units (IU)/kg/day subcutaneously (SC)
once daily (QD) on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
After completion of study treatment, patients are followed up at 3 months.
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