NCT06886516

Apixaban in Thrombocytopenia

ADAPTiON: Apixaban Dose Adjustment in Patient With Thrombocytopenia in ONcology

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Rushad Patell · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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.

Conditions

• Deep Vein Thrombosis
• Pulmonary Embolism and Thrombosis
• Thrombocytopenia
• Recurrent Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Apixaban	A factor Xa inhibitor, 2.5 and 5 mg tablets, by mouth per protocol.

Timeline

• Start date: 2025-02-28
• Primary completion: 2027-07-01
• Completion: 2029-07-01
• First posted: 2025-03-20
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study