Apixaban for Blood Clot and Low Platelet Count

Recruiting in Palo Alto (17 mi)

Overseen byRushad Patell, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Rushad Patell

No Placebo Group

Trial Summary

What is the purpose of this trial?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)

Eligibility Criteria

This trial is for adults over 18 with cancer-related blood clots or low platelet counts. They must have had a confirmed clot diagnosis within the last month, no active bleeding, and no major hemorrhage in the past year. Participants should not have brain metastases and must be able to tolerate platelet transfusions.

Inclusion Criteria

I am 18 years old or older.

I can take care of myself but might not be able to do heavy physical work.

Participants must agree to use adequate contraception prior to study entry and for the duration of study participation if of child-bearing potential

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Exclusion Criteria

I have had a procedure to remove a blood clot or prevent clots.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to apixaban

I do not have severe kidney (stage IV CKD or higher) or liver disease (Child Pugh B/C).

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Participant Groups

The study tests a novel dose-adjusted apixaban (an anticoagulant) for safety and effectiveness in managing venous thromboembolism (blood clots) in patients with cancer who also have low platelets due to thrombocytopenia.

1Treatment groups

Experimental Treatment

Group I: DOSE-ADJUSTED APIXABANExperimental Treatment1 Intervention

30 enrolled participants will complete study procedures as follows: * Baseline visit with assessments * Predetermined dose of Apixiban 2x daily for 90 days * Off treatment visit 7 days after last study drug dose * Follow up visit 6 weeks after last study drug dose