DOAC - Dosing Options in AntiCoagulation Prophylaxis

Part of paid clinical trials in Burlington, Vermont.

Sponsor
University of Vermont
Study ID
NCT07005024
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cancer
  • VTE (Venous Thromboembolism)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apixaban 2.5 mg twice daily — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 17, 2025
Status verified
Feb 2026
Primary completion
Aug 31, 2035
Completion
Aug 31, 2035

Study Design

Enrollment
996 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Vermont Medical CenterBurlingtonVermont05401
Steven Ades, MD, MSc
[email protected]
7739804380

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By research site
University of Vermont Medical Center· Burlington, VT

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