CancerPhase 3DOACNCT07005024
DOAC - Dosing Options in AntiCoagulation Prophylaxis
A Phase 3 study testing Apixaban 2.5 mg twice daily, Apixaban 5 mg once daily and No anticoagulation in people with Cancer and VTE (Venous Thromboembolism), run by University of Vermont at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, VTE (Venous Thromboembolism)
- What is being tested?
- Apixaban 2.5 mg twice daily, Apixaban 5 mg once daily and No anticoagulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 996 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2025to Aug 2035
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Steven Ades, MD, MSc, 7739804380, steven.ades@med.uvm.edu
About this study
Official title: A Comparison of Anticoagulant Dosing Strategies to Reduce VTE and Mortality in Cancer Outpatients: A Randomized, Pragmatic Trial
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.
Read more
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.
Read the detailed description
Venous thromboembolism (VTE) is a leading cause of morbidity and mortality in ambulatory patients with cancer, particularly within the first several months after initiating cancer-directed therapy (CDT). The Khorana Risk Score (KRS) is a validated tool used to identify cancer patients at increased risk of VTE. While patients with a KRS ≥ 2 are eligible for VTE prophylaxis under current clinical guidelines, there remains a major gap between these recommendations and clinical practice. Implementation of prophylaxis is low due to concerns about bleeding, uncertainty regarding net clinical benefit, and challenges with medication adherence-particularly with twice-daily dosing regimens.
Apixaban, a direct oral anticoagulant (DOAC), is FDA-approved and supported by NCCN and ASH guidelines for VTE prevention in high-risk ambulatory cancer patients. The AVERT trial demonstrated that apixaban 2.5 mg twice daily significantly reduced VTE events in cancer patients with a KRS ≥ 2 but increased the risk of major bleeding. However, this dosing strategy remains underutilized. The possibility of once-daily dosing with apixaban, which could improve adherence and acceptance among patients and physicians, has not been adequately studied in this population.
This single-center, phase III, open-label, pragmatic randomized clinical trial will evaluate two dosing strategies of apixaban for VTE prevention in cancer outpatients with a KRS of 2. A total of 996 participants will be randomized 1:1:1 to receive:
Arm 1: Apixaban 2.5 mg twice daily
Arm 2: Apixaban 5 mg once daily
Arm 3: No anticoagulant prophylaxis (standard care)
The primary objective is to compare the incidence of VTE across these arms over a 6-month treatment period. Secondary objectives include comparisons of all-cause mortality and rates of clinically significant bleeding events (CTCAE grade ≥ 3).
Participants must have a solid tumor or lymphoma and be initiating or recently initiated on CDT. Those with recent VTE, active anticoagulation for another indication, hematologic malignancies (e.g., acute leukemia, myeloma), or high bleeding risk are excluded.
Randomization occurs after eligibility is confirmed via chart review and informed consent is obtained. In line with a pragmatic trial design, there are no mandated study visits beyond a brief 2-month patient-reported outcomes (PRO) check-in. All other data, including VTE events, mortality, bleeding, and adherence, are captured via electronic health record abstraction and PRO questionnaires.
Drug is not provided as part of the study; apixaban will be prescribed as part of usual clinical care and filled through the participant's pharmacy. Participants who are unable to obtain the drug due to insurance or financial barriers will still be followed in their assigned study arm per intent-to-treat principles.
The study will use a formal interim analysis following the O'Brien and Fleming approach, with stopping rules for futility and efficacy. Final analyses will compare VTE incidence and other endpoints using chi-square tests and Kaplan-Meier survival analysis, as appropriate.
This trial is designed to generate real-world evidence to inform anticoagulant prescribing practices in cancer outpatients at intermediate risk for VTE. Results may support broader, more personalized adoption of thromboprophylaxis strategies that balance effectiveness, safety, and feasibility.
- Conditions
- Cancer, VTE (Venous Thromboembolism)
- Being tested
- Apixaban 2.5 mg twice daily, Apixaban 5 mg once daily, No anticoagulation
- Keywords
- Apixaban
- Medical subject headings
- Neoplasms, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apixaban 2.5 mg twice dailyDrug
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 dailyDrug
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 anticoagulationDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: No anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
All-Cause Mortality in Participants Receiving Apixaban 2.5 mg Twice Daily vs No Anticoagulation
This outcome compares all-cause mortality at 6 months between participants randomized to apixaban 2.5 mg twice daily and those receiving no anticoagulation prophylaxis. Vital status will be determined through medical record review and/or survival follow-up.
Measured: 6 months
All-Cause Mortality in Participants Receiving Apixaban 5 mg Once Daily vs No Anticoagulation
This outcome compares all-cause mortality at 6 months between participants receiving apixaban 5 mg once daily and those receiving no anticoagulation. Vital status will be assessed using clinical follow-up and medical record review.
Measured: 6 months
Incidence of Clinically Significant Bleeding Events (CTCAE Grade ≥3)
This outcome evaluates the incidence of clinically significant bleeding events (CTCAE v5.0 Grade ≥3) in participants randomized to apixaban 2.5 mg twice daily, 5 mg once daily, or no anticoagulation. Events include bleeding requiring hospitalization, transfusion, or occurring at critical sites (e.g., intracranial, GI). Bleeding events will be identified through routine clinical care and confirmed via chart review.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start17 Oct 2025
- Primary completionAug 2035 (estimated)
- Study completionAug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 996 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Ades, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005024
- Sponsor's protocol ID
- UVMCC2505/STUDY00003696
- Acronym
- DOAC
- Status last verified
- Feb 2026
- First submitted
- 26 May 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Anticoagulant Dosing Strategies to Reduce VTE and Mortality in Cancer Outpatients: A Randomized, Pragmatic Trial
- ClinicalTrials.gov ID
- NCT07005024
- Acronym / sponsor ID
- DOAC / UVMCC2505/STUDY00003696
- Conditions
- Cancer, VTE (Venous Thromboembolism)
- Keywords
- Apixaban
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 996 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- Aug 2035 (estimated)
- Study completion
- Aug 2035 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Venous thromboembolism (VTE) is a leading cause of morbidity and mortality in ambulatory patients with cancer, particularly within the first several months after initiating cancer-directed therapy (CDT). The Khorana Risk Score (KRS) is a validated tool used to identify cancer patients at increased risk of VTE. While patients with a KRS ≥ 2 are eligible for VTE prophylaxis under current clinical guidelines, there remains a major gap between these recommendations and clinical practice. Implementation of prophylaxis is low due to concerns about bleeding, uncertainty regarding net clinical benefit, and challenges with medication adherence-particularly with twice-daily dosing regimens.
Apixaban, a direct oral anticoagulant (DOAC), is FDA-approved and supported by NCCN and ASH guidelines for VTE prevention in high-risk ambulatory cancer patients. The AVERT trial demonstrated that apixaban 2.5 mg twice daily significantly reduced VTE events in cancer patients with a KRS ≥ 2 but increased the risk of major bleeding. However, this dosing strategy remains underutilized. The possibility of once-daily dosing with apixaban, which could improve adherence and acceptance among patients and physicians, has not been adequately studied in this population.
This single-center, phase III, open-label, pragmatic randomized clinical trial will evaluate two dosing strategies of apixaban for VTE prevention in cancer outpatients with a KRS of 2. A total of 996 participants will be randomized 1:1:1 to receive:
Arm 1: Apixaban 2.5 mg twice daily
Arm 2: Apixaban 5 mg once daily
Arm 3: No anticoagulant prophylaxis (standard care)
The primary objective is to compare the incidence of VTE across these arms over a 6-month treatment period. Secondary objectives include comparisons of all-cause mortality and rates of clinically significant bleeding events (CTCAE grade ≥ 3).
Participants must have a solid tumor or lymphoma and be initiating or recently initiated on CDT. Those with recent VTE, active anticoagulation for another indication, hematologic malignancies (e.g., acute leukemia, myeloma), or high bleeding risk are excluded.
Randomization occurs after eligibility is confirmed via chart review and informed consent is obtained. In line with a pragmatic trial design, there are no mandated study visits beyond a brief 2-month patient-reported outcomes (PRO) check-in. All other data, including VTE events, mortality, bleeding, and adherence, are captured via electronic health record abstraction and PRO questionnaires.
Drug is not provided as part of the study; apixaban will be prescribed as part of usual clinical care and filled through the participant's pharmacy. Participants who are unable to obtain the drug due to insurance or financial barriers will still be followed in their assigned study arm per intent-to-treat principles.
The study will use a formal interim analysis following the O'Brien and Fleming approach, with stopping rules for futility and efficacy. Final analyses will compare VTE incidence and other endpoints using chi-square tests and Kaplan-Meier survival analysis, as appropriate.
This trial is designed to generate real-world evidence to inform anticoagulant prescribing practices in cancer outpatients at intermediate risk for VTE. Results may support broader, more personalized adoption of thromboprophylaxis strategies that balance effectiveness, safety, and feasibility.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Apixaban 2.5 mg Twice Daily Prophylaxis | Experimental | Drug: Apixaban 2.5 mg twice dailyParticipants 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. |
| Arm 2 Title: Apixaban 5 mg Once Daily Prophylaxis | Experimental | Drug: Apixaban 5 mg once dailyParticipants 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. |
| No Anticoagulation (Control) | Active comparator | Drug: No anticoagulationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apixaban 2.5 mg twice dailyApixaban, 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. | Drug | Arm 1: Apixaban 2.5 mg Twice Daily Prophylaxis |
| Apixaban 5 mg once dailyApixaban 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. | Drug | Arm 2 Title: Apixaban 5 mg Once Daily Prophylaxis |
| No anticoagulationParticipants 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. | Drug | No Anticoagulation (Control) |
Primary outcome
Incidence of VTE in Participants Receiving Apixaban 2.5 mg Twice Daily vs No Anticoagulation
Time frame: 6 months
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.
Incidence of VTE in Participants Receiving Apixaban 5 mg Once Daily vs No Anticoagulation
Time frame: 6 months
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.
3 secondary outcomes
All-Cause Mortality in Participants Receiving Apixaban 2.5 mg Twice Daily vs No Anticoagulation
Time frame: 6 months
All-Cause Mortality in Participants Receiving Apixaban 5 mg Once Daily vs No Anticoagulation
Time frame: 6 months
Incidence of Clinically Significant Bleeding Events (CTCAE Grade ≥3)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No. Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apixaban 2.5 mg twice daily, Apixaban 5 mg once daily and No anticoagulation in people with Cancer and VTE (Venous Thromboembolism), run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven Ades, MD, MSc (1 (802) 656-2021, steven.ades@med.uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of VTE in Participants Receiving Apixaban 2.5 mg Twice Daily vs No Anticoagulation (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.