Apixaban in Thrombocytopenia

NCT06886516 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 24-110
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

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

Keywords

Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism; Thrombocytopenia; Thromboembolism; Recurrent Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Study Enrollment

  Study enrollment is defined as documentation of informed consent for participants approached.

  Up to 5 years

Secondary Outcomes (7)

• Rate of Enrolled Participants With Administration of at Least 1 Dose of Apixaban

  Up to 3 months

• Study Drug Adherence Rate

  Up to 3 months

• Platelet Count Monitoring Plan Adherence Rate

  Up to 3 months

• Study Completion Rate

  Up to 3 months

• Major Bleeding Rate

  Up to 3 months

Study Arms (1)

DOSE-ADJUSTED APIXABAN

EXPERIMENTAL

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

Drug: Apixaban

Interventions

Apixaban DRUG

A factor Xa inhibitor, 2.5 and 5 mg tablets, by mouth per protocol.

Also known as: 1-(4methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4c]pyridine-3-carboxamide, C25H25N5O4

DOSE-ADJUSTED APIXABAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 therapy with undetectable viral load within 6 months are eligible for this trial.
• For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

You may not qualify if:

• Participants who are receiving any other investigational agents.
• Participants who have had a thrombectomy, insertion of a caval filter, or require a fibrinolytic agent.
• Participants that have index events with severe clot burden defined as bilateral proximal lower extremity deep vein thrombosis and saddle embolism or pulmonary embolism with hemodynamic compromise.
• Participants with acute myeloid leukemia or myelodysplastic syndrome or who are undergoing or have undergone allogeneic stem cell transplant.
• Participants with luminal gastrointestinal malignancy or genitourinary cancer.
• Presence of known or prior brain metastasis, given the increased risk of life-threatening intracranial hemorrhage with anticoagulant use. While screening for brain metastases is not standard of care in this population, investigators may obtain brain imaging if clinically indicated prior to initiation of anticoagulation. Imaging is not mandated in order to participate in this study.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to apixaban.
• Participants receiving any medications or substances that are inhibitors or inducers of CYP3A/P-gp are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
• Participants on aspirin (\>100 mg/day), dual antiplatelet therapy, or receiving chronic treatment with NSAIDS
• Participants with uncontrolled intercurrent illness.
• Participants at high risk of bleeding such as:
• Unresected luminal/mucosal GI and GU cancers
• Active gastric or duodenal cancer
• History of major bleeding (based on ISTH criteria) in the past 12 months
• Any prior history of Intracranial hemorrhage (microhemorrhage is not included)

Sponsors & Collaborators

• Rushad Patell: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Thrombosis; Thrombocytopenia; Venous Thromboembolism; Thromboembolism

Interventions

apixaban

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Rushad Patell, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rushad Patell, MD

CONTACT

617-667-9179; rpatell@bidmc.harvard.edu

Fernanda De Queiroz Silva, MD

CONTACT

617-667-9920; fdequeir@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

Locations

US (1)