Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07005024

DOAC - Dosing Options in AntiCoagulation Prophylaxis

Led by University of Vermont · Updated on 2026-02-05

996

Participants Needed

1

Research Sites

510 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

DOAC - Dosing Options in AntiCoagulation Prophylaxis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with an active solid tumor or lymphoma
  • Starting a new systemic cancer treatment or changing cancer treatment
  • Khorana Risk Score of 2 at treatment start
  • Not currently receiving therapeutic anticoagulation
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Active bleeding or high risk of bleeding (such as recent major surgery or brain tumors prone to bleeding)
  • Known allergy or contraindication to apixaban (including severe liver disease or certain drug interactions)
  • Currently taking therapeutic-dose anticoagulation for blood clots or atrial fibrillation
  • Platelet count below 50,000 per microliter
  • Creatinine clearance less than 25 mL/min
  • Life expectancy under 3 months
  • Pregnant or breastfeeding
  • Unable to comply with study procedures

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Vermont Medical Center

Burlington, Vermont, United States, 05401

Actively Recruiting

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Research Team

S

Steven Ades, MD, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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