Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06886516

Apixaban in Thrombocytopenia

Led by Rushad Patell · Updated on 2026-04-15

30

Participants Needed

1

Research Sites

226 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

Apixaban in Thrombocytopenia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed active cancer diagnosed within the last 6 months or cancer treatment received within the last 6 months
  • Newly diagnosed symptomatic deep vein thrombosis or pulmonary embolism confirmed by imaging within 28 days before enrollment
  • Platelet count less than 75,000 per microliter before any platelet transfusion within 28 days of blood clot diagnosis
  • Platelet count shows response to transfusion if previously given (increase of at least 10,000 per microliter over last 3 transfusions)
  • No signs of active bleeding currently
  • No major bleeding episodes requiring transfusion, hospitalization, or intervention in the past 12 months
  • No known brain metastases
  • Age 18 years or older
  • ECOG performance status of 2 or less
  • Adequate organ and marrow function including bilirubin, liver enzymes, and kidney function within specified limits
  • HIV-infected participants on effective therapy with undetectable viral load within 6 months are eligible
  • For chronic hepatitis B infection, viral load must be undetectable on suppressive therapy if needed
  • Participants with hepatitis C must be cured or have undetectable viral load if currently treated
  • Women of childbearing potential and men must agree to use effective contraception during and after the study
  • Ability and willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • Receiving any other investigational drugs
  • History of thrombectomy, caval filter placement, or need for fibrinolytic agents
  • Severe clot burden such as bilateral proximal deep vein thrombosis or pulmonary embolism with hemodynamic compromise
  • Diagnosis of acute myeloid leukemia, myelodysplastic syndrome, or history of allogeneic stem cell transplant
  • Luminal gastrointestinal or genitourinary cancers
  • Known or prior brain metastases
  • Allergic reactions to drugs similar to apixaban
  • Taking medications that strongly affect CYP3A or P-gp enzymes
  • Use of aspirin over 100 mg/day, dual antiplatelet therapy, or chronic NSAIDs
  • Uncontrolled illnesses
  • High risk of bleeding including unresected mucosal cancers, active gastric or duodenal cancer, recent major bleeding, or prior intracranial hemorrhage
  • Ongoing disseminated intravascular coagulation
  • Severe kidney disease (Stage IV or worse) or advanced liver disease (Child Pugh B/C)
  • Planned major surgery during the study
  • Psychiatric or social issues limiting study compliance
  • Pregnant or breastfeeding women
  • Unable to swallow pills

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

R

Rushad Patell, MD

CONTACT

F

Fernanda De Queiroz Silva, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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