This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood). Investigators are also looking to see if participants on this treatment have fewer bleeding episodes.
The name of the study drug involved in this study is:
-Apixiban (a type of anticoagulant)
Active malignancy defined as histologically confirmed diagnosis within last 6 months or received any cancer directed therapy within the last 6 months.
Radiologically confirmed newly diagnosed symptomatic deep vein thrombosis or pulmonary embolism within 28 days of enrollment. Includes proximal lower-limb DVT or symptomatic PE. Upper extremity or catheter-associated thrombosis will be included, as will distal lower extremity DVTs.
Platelet count < 75,000/ml (prior to platelet transfusion) within 28 days of VTE diagnosis.
Platelet count responsive to transfusion if previously administered (defined as an average platelet increase of at least 10,000/ml over the last 3 transfusions.
Participants who are receiving any other investigational agents.
Participants who have had a thrombectomy, insertion of a caval filter, or require a fibrinolytic agent.
Participants that have index events with severe clot burden defined as bilateral proximal lower extremity deep vein thrombosis and saddle embolism or pulmonary embolism with hemodynamic compromise.
Participants with acute myeloid leukemia or myelodysplastic syndrome or who are undergoing or have undergone allogeneic stem cell transplant.
Single group
Apixaban
DrugA factor Xa inhibitor, 2.5 and 5 mg tablets, by mouth per protocol.
Study Enrollment
Study enrollment is defined as documentation of informed consent for participants approached.
Rate of Enrolled Participants With Administration of at Least 1 Dose of Apixaban
Feasibility is achieved if 75% of participants received at least 1 dose of apixaban.
Study Drug Adherence Rate
Study drug adherence is defined as the proportion of participants that take over 80% of prescribed doses based on pill count. Success is defined as 75% or above.
Platelet Count Monitoring Plan Adherence Rate
Platelet Count Monitoring Plan Adherence Rate is defined as proportion of participants that receive at least 80% of platelet counts within frequency stipulated by the study protocol. Success is defined as 75% or above.
Study Completion Rate
Study is completed when participants finish the 90-day period or terminate due to event that qualifies as an outcome.
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Rushad Patell
Lead sponsor
Beth Israel Deaconess Medical Center
Sponsor institution
