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)
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). This study is a feasibility study, which is the first-time investigators are examining this drug, Apixaban, for cancer-associate VTE or thrombocytopenia. Investigators are also looking to see if participants on this treatment have fewer bleeding episodes. The U.S. Food and Drug Administration (FDA) has approved apixaban as a treatment option for venous thromboembolism (VTE) and stroke prevention in patients with atrial fibrillation (irregular and fast heartbeat). This study is investigating apixaban taken by mouth (with adjusted doses) as a treatment for VTE in participants with active malignancies (cancer) and thrombocytopenia which has not been studied or FDA approved. The research study procedures include screening for eligibility, in-clinic visits, and blood tests. Participants will receive study treatment for 90 days and will be followed for 6 weeks after stopping study treatment. It is expected that about 30 people will take part in this research study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
A factor Xa inhibitor, 2.5 and 5 mg tablets, by mouth per protocol.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGStudy Enrollment
Study enrollment is defined as documentation of informed consent for participants approached.
Time frame: Up to 5 years
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.
Time frame: Up to 3 months
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.
Time frame: Up to 3 months
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.
Time frame: Up to 3 months
Study Completion Rate
Study is completed when participants finish the 90-day period or terminate due to event that qualifies as an outcome.
Time frame: Up to 3 months
Major Bleeding Rate
Major bleeding rate is defined as the proportion of participants who experience major bleeding during the study.
Time frame: Up to 3 months
Clinically Relevant Non-Major Bleeding Rate
Clinically relevant major bleeding rate is defined as the proportion of participants who experience a clinically relevant non-major bleeding event.
Time frame: Up to 3 months
Recurrent Venous Thromboembolism Rate (VTE)
Recurrent VTE rate is defined as the proportion of participants who experience recurrent VTE, including pulmonary embolism and lower extremity deep vein thrombosis.
Time frame: Up to 3 months
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