Recruiting
Phase 3

Apixaban

Sponsor:

University of Vermont

Code:

NCT07005024

Conditions

Cancer

VTE (Venous Thromboembolism)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Apixaban 2.5 mg twice daily

Apixaban 5 mg once daily

No anticoagulation

Study Details

Brief summary:

Blood clots, also known as venous thromboembolism (VTE), are a common and serious complication for people with cancer. They can lead to pain, hospitalizations, delayed cancer treatment, and even death. Although national guidelines recommend using blood thinners (anticoagulants) to prevent clots in cancer patients who are at higher risk, these medications are not commonly prescribed due to concerns about bleeding and inconvenience.

This study will test different ways of using a commonly prescribed blood thinner called apixaban (brand name Eliquis) to see if it can safely and effectively reduce the risk of blood clots and death in cancer patients who are at moderate risk for VTE. The study focuses on people who have a "Khorana score" of 2, which puts them at intermediate risk for developing blood clots.

The study will include approximately 996 participants with solid tumors or lymphoma who are starting or recently started cancer-directed therapy. Participants will be randomly assigned to one of three groups:

Group 1: Apixaban 2.5 mg twice a day (standard prophylactic dose)

Group 2: Apixaban 5 mg once a day (an alternative, more convenient dose)

Group 3: No anticoagulant (standard care)

Participants will take the assigned treatment (if applicable) for 6 months. Researchers will monitor whether participants develop blood clots, experience serious bleeding events, or die from any cause during the study period.

By comparing these three groups, the researchers hope to learn whether a once-daily dose of apixaban can work as well as the standard twice-daily dose, and whether either dosing strategy is better than no anticoagulation at all. If successful, the study may help increase the safe use of VTE prevention in cancer patients and improve overall outcomes, especially in patients at intermediate risk.

This is a pragmatic trial, meaning it is designed to fit into real-world clinical practice with minimal extra procedures. The study drug is not provided by the sponsor and will be prescribed and filled through usual care channels. Participants and their doctors will decide whether to continue the medication after the study ends.

Conditions

Cancer

VTE (Venous Thromboembolism)

Study ID

NCT07005024

Start date

Oct 17, 2025

Status verified date

Feb, 2026

Completion date

Aug, 2035

Anticipated

Primary completion date

Aug, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosed with an active solid tumor or lymphoma
  • Starting a new systemic cancer treatment or changing cancer treatment
  • Khorana Risk Score of 2 (calculated based on lab and clinical data at treatment initiation)
  • Not currently receiving therapeutic anticoagulation
  • Able to provide informed consent

Exclusion Criteria:

  • Active bleeding or high risk of bleeding (e.g., recent major surgery, CNS tumors with hemorrhagic risk)
  • Known contraindication to apixaban (e.g., allergy, severe liver disease, dual strong CYP3A4 and P-gp inhibitors)
  • Current therapeutic-dose anticoagulation for VTE or atrial fibrillation
  • Platelet count < 50,000/µL
  • Creatinine clearance < 25 mL/min
  • Life expectancy < 3 months
  • Pregnant or breastfeeding
  • Inability to comply with study procedures

Study Design

Enrollment

996 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm 1: Apixaban 2.5 mg Twice Daily Prophylaxis

Participants in this arm will receive apixaban 2.5 mg by mouth twice daily (BID) for 6 months. This is the guideline-supported prophylactic dose for VTE prevention in high-risk ambulatory cancer patients.

experimental: Arm 2 Title: Apixaban 5 mg Once Daily Prophylaxis

Participants in this arm will receive apixaban 5 mg by mouth once daily for 6 months. This alternative dosing schedule is being tested for its potential to improve adherence and maintain VTE protection in moderately high-risk cancer outpatients.

active comparator: No Anticoagulation (Control)

Participants in this arm will not receive any anticoagulant prophylaxis. This approach reflects current standard-of-care practice for many patients with a Khorana Risk Score of 2, where anticoagulation is not routinely prescribed.

Interventions

Apixaban 2.5 mg twice daily

Apixaban, a direct oral anticoagulant (DOAC), will be administered at a prophylactic dose of 2.5 mg by mouth twice daily for 6 months. This dose is guideline-recommended for VTE prevention in high-risk ambulatory cancer patients. Participants will continue their cancer-directed therapy during this time. No study-mandated visits or labs are required beyond standard care.

Apixaban 5 mg once daily

Apixaban will be administered at 5 mg by mouth once daily for 6 months. This alternative prophylactic schedule is being studied to assess its effectiveness and adherence in patients with a Khorana Risk Score of 2. Participants will continue their usual cancer treatment. This arm evaluates a simplified dosing strategy in a real-world, pragmatic design.

No anticoagulation

Participants randomized to this arm will not receive apixaban or any other anticoagulant for VTE prevention. This reflects current standard care for many cancer outpatients with moderate risk (Khorana Score = 2). Outcomes will be monitored through routine care and medical record abstraction.

Primary outcome measure

  • Incidence of VTE in Participants Receiving Apixaban 2.5 mg Twice Daily vs No Anticoagulation [ Time Frame: 6 months ]
  • Incidence of VTE in Participants Receiving Apixaban 5 mg Once Daily vs No Anticoagulation [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Steven Ades, MD, MSc

1 (802) 656-2021steven.ades@med.uvm.edu

Locations

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Steven Ades, MD, MSc

7739804380steven.ades@med.uvm.edu

More Information

Sponsor

University of Vermont

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • Apixaban

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont on 2026-02-05.