DOAC - Dosing Options in AntiCoagulation Prophylaxis

NCT07005024 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: UVMCC2505/STUDY00003696
• Study Type: interventional
• Target: 996
• Locations: 1 country
• Sites: 1

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)

Keywords

Apixaban

Outcome Measures

Primary Outcomes (2)

• Incidence of VTE in Participants Receiving Apixaban 2.5 mg Twice Daily vs No Anticoagulation

  This outcome compares the incidence of venous thromboembolism (VTE) - including deep vein thrombosis, pulmonary embolism, and other clinically relevant thromboses - between participants receiving apixaban 2.5 mg BID and those receiving no anticoagulation prophylaxis. Events will be identified through clinical care and confirmed via chart review. Both symptomatic and incidental VTEs will be included.

  6 months

• Incidence of VTE in Participants Receiving Apixaban 5 mg Once Daily vs No Anticoagulation

  This outcome compares the incidence of venous thromboembolism (VTE) between participants randomized to apixaban 5 mg once daily and those receiving no anticoagulation. VTEs may include DVT, PE, or other thromboses, whether symptomatic or incidental. Events will be confirmed through medical record review. The goal is to determine whether this simplified dosing schedule provides effective VTE prevention in cancer patients with Khorana Risk Score of 2.

  6 months

Secondary Outcomes (3)

• All-Cause Mortality in Participants Receiving Apixaban 2.5 mg Twice Daily vs No Anticoagulation

  6 months

• All-Cause Mortality in Participants Receiving Apixaban 5 mg Once Daily vs No Anticoagulation

  6 months

• Incidence of Clinically Significant Bleeding Events (CTCAE Grade ≥3)

  6 months

Study Arms (3)

Arm 1: Apixaban 2.5 mg Twice Daily Prophylaxis

EXPERIMENTAL

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.

Drug: Apixaban 2.5 mg twice daily

Arm 2 Title: Apixaban 5 mg Once Daily Prophylaxis

EXPERIMENTAL

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.

Drug: Apixaban 5 mg once daily

No Anticoagulation (Control)

ACTIVE COMPARATOR

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.

Drug: No anticoagulation

Interventions

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.

Arm 2 Title: Apixaban 5 mg Once Daily Prophylaxis

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.

Arm 1: Apixaban 2.5 mg Twice Daily Prophylaxis

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.

No Anticoagulation (Control)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Venous Thromboembolism

Interventions

apixaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Steven Ades, MD, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: Participants are randomized in a 1:1:1 ratio to one of three parallel arms: apixaban 2.5 mg twice daily, apixaban 5 mg once daily, or no anticoagulation. All arms reflect standard-of-care approaches for cancer outpatients with moderate VTE risk (Khorana Risk Score = 2). Participants remain in their assigned group for 6 months. The study uses a pragmatic design with limited protocol-mandated procedures to reflect real-world practice.

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: October 17, 2025
• Primary Completion (Estimated): August 1, 2035
• Study Completion (Estimated): August 1, 2035
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)