Apixaban in Thrombocytopenia (NCT06886516) | Clinical Trial Compass
RecruitingEarly Phase 1
Apixaban in Thrombocytopenia
United States30 participantsStarted 2025-02-28
Plain-language summary
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)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
* No evidence of active hemorrhage.
* No recent history of major hemorrhage (requiring transfusion, hospitalization or intervention) within the last 12 months.
* No known brain metastases.
* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of apixaban in participants \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
* ECOG performance status ≤2
* Participants must have adequate organ and marrow function as defined below:
* Total bilirubin ≤ institutional upper limit of normal (ULN)
* AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
* Glomerular filtration rate (GFR) ≥25 mL/min/1.73/m2
* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral the…