CSP #2037T - Veterans Affairs Learning Health System Initiative to Assess Novel Screening vs. Usual Care and Treatment With Apixaban vs. Rivaroxaban in Veterans With Atrial Fibrillation (VALIANT-AF-T) Trial
VA trial compares two common blood thinners for atrial fibrillation
Plain English Summary
Comparing the Safety and Efficacy of Apixaban and Rivaroxaban is a Phase 4 clinical trial sponsored by VA Office of Research and Development studying Atrial Fibrillation. This study tests if apixaban (Eliquis) or rivaroxaban (Xarelto) are better at preventing strokes, major bleeding, or death in veterans with atrial fibrillation. It is for male or female veterans aged 22 and older who have been diagnosed with atrial fibrillation or flutter and are already taking one of these two medications. Participation involves being randomly assigned to continue taking either apixaban or rivaroxaban, with data collected from electronic health records. Alternatives include continuing current treatment as prescribed by a doctor outside of a clinical trial, or discussing other treatment options with a healthcare provider. The trial aims to enroll 10000 participants.
Official Summary
* The trial will compare two anticoagulants ("blood thinners") that are currently used in the VA and are considered standard care to prevent strokes in patients with atrial fibrillation. The two most commonly-used anticoagulants will be compared: apixaban (Eliquis) and rivaroxaban (Xarelto). They are considered by many doctors to have similar benefits and risks, but no one knows for sure. * The trial only enrolls patients with a diagnosis of atrial fibrillation ("A Fib") or atrial flutter. Most participants will be age 65 or older, and should already be taking apixaban or rivaroxaban. * The investigators will measure, in about 10,000 VA patients nationally, whether the rates of stroke, major bleeding, or death differ between these two drugs. * The trial will last about 7 years, but after the first prescription, all information will be collected from electronic medical records.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are a veteran, 22 years or older, have atrial fibrillation or flutter, and are currently taking apixaban or rivaroxaban. You cannot join if you are currently taking a different blood thinner that cannot be switched, have another condition requiring blood thinners (like a blood clot), or have a known bleeding disorder. You also cannot join if you are pregnant or breastfeeding, have allergies to either drug, have very poor kidney function (eGFR < 30), have a mechanical heart valve, or have had recent heart or chest surgery. This trial is studying Atrial Fibrillation, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how often participants experience major bleeding, stroke, or death over three years, indicating which drug might be safer and more effective for preventing serious health The specific primary outcome measures are: Onset of ISTH Major Bleeding Event (3 years); Time to First Stroke (3 years); Time to First Systemic Embolism (3 years); Time to All-Cause Mortality (3 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial matters because it will provide crucial data on the comparative safety and effectiveness of two widely used blood thinners, helping to optimize stroke prevention for veterans with atrial fi This research targets Atrial Fibrillation, where improved treatment options are needed.
Investor Insight
This large-scale, 7-year trial involving 10,000 patients signals a significant investment in understanding standard-of-care treatments, with high approval probability for findings that refine current This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes. The large enrollment target of 10000 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if you are eligible and what the potential benefits and risks are for you. Understand that you will be randomly assigned to continue one of the two medications, and your health information will be gathered from your VA electronic medical records. Be prepared for regular check-ins and to report any new symptoms or side effects to your healthcare team. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 10,000 participants
Interventions
- DRUG: Apixaban — Study participants will be randomized to twice daily oral administration of apixaban 5mg. Reduced dose apixaban (2.5 mg twice daily) will be given to participants who meet 2 of the 3 criteria: age 80 years, body weight 60 kg, and serum creatinine 1.5 mg/dL.
- DRUG: Rivaroxaban — Study participants will be randomized to daily oral administration of rivaroxaban 20mg. Reduced dose rivaroxaban (15 mg once daily) will be given to participants with a creatinine clearance 15-50 mL/min.
Primary Outcomes
- Onset of ISTH Major Bleeding Event (3 years)
- Time to First Stroke (3 years)
- Time to First Systemic Embolism (3 years)
- Time to All-Cause Mortality (3 years)
Secondary Outcomes
- Time to First Stroke, Systemic Embolism, or All-Cause Mortality (3 years)
- Time to First Stroke (3 years)
- Time to First Hospitalization for Heart Failure, Myocardial Infarction, or Acute Coronary Syndrome (3 years)
- Time to First systemic embolism (3 years)
- All-Cause Mortality (3 years)
Full Eligibility Criteria
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Male or female Veteran, aged 22 years or older 2. Diagnosis of atrial fibrillation (AF) or atrial flutter (AFL) and currently taking either apixaban or rivaroxaban. 3. CHA2DS2-Vasc of 3 or more 4. Ability to take oral medication and self-reported willingness to adhere to the prespecified apixaban or rivaroxaban regimen Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study; notably use of antiplatelet agents or prior OAC use will not be an exclusion criterion: 1. Current use of oral or injectable anticoagulation, without ability to switch to the assigned study medication 2. Another indication for anticoagulation, such as pulmonary embolism 3. Contraindication to oral anticoagulation 4. Known bleeding diathesis 5. Documented current pregnancy or lactation in the EHR or self-reported current pregnancy or lactation 6. Known allergic reactions or intolerance to apixaban or rivaroxaban 7. Most recent estimated glomerular filtration rate (eGFR) is \< 30 mL/minute/1.73m2. An eGFR result must have been obtained within 18 months before randomization. 8. Known mechanical heart valve 9. Known moderate-severe mitral stenosis 10. Known history of left atrial occlusion, excision, or ligation 11. Current or planned use of systemic ritonavir, itraconazole, or ketoconazole (topical use of ketoconazole only is allowed) 12. Cardiac or thoracic surgery in the past 3 months
Trial Locations
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, Massachusetts, United States
Frequently Asked Questions
What is clinical trial NCT06953726?
NCT06953726 is a Phase 4 INTERVENTIONAL study titled "Comparing the Safety and Efficacy of Apixaban and Rivaroxaban." It is currently not yet recruiting and is sponsored by VA Office of Research and Development. The trial targets enrollment of 10000 participants.
What conditions does NCT06953726 study?
This trial investigates treatments for Atrial Fibrillation. The primary condition under study is Atrial Fibrillation.
What treatments are being tested in NCT06953726?
The interventions being studied include: Apixaban (DRUG), Rivaroxaban (DRUG). Study participants will be randomized to twice daily oral administration of apixaban 5mg. Reduced dose apixaban (2.5 mg twice daily) will be given to participants who meet 2 of the 3 criteria: age 80 years, body weight 60 kg, and serum creatinine 1.5 mg/dL.
What does Phase 4 mean for NCT06953726?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT06953726?
This trial is currently "Not Yet Recruiting." It started on 2026-06-01. The estimated completion date is 2033-10-03.
Who is sponsoring NCT06953726?
NCT06953726 is sponsored by VA Office of Research and Development. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06953726?
The trial aims to enroll 10000 participants. The trial has not yet started recruiting.
How is NCT06953726 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06953726?
The primary outcome measures are: Onset of ISTH Major Bleeding Event (3 years); Time to First Stroke (3 years); Time to First Systemic Embolism (3 years); Time to All-Cause Mortality (3 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06953726 being conducted?
This trial is being conducted at 1 site, including Boston, Massachusetts (United States).
Where can I find official information about NCT06953726?
The official record for NCT06953726 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06953726. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06953726 testing in simple terms?
This study tests if apixaban (Eliquis) or rivaroxaban (Xarelto) are better at preventing strokes, major bleeding, or death in veterans with atrial fibrillation. It is for male or female veterans aged 22 and older who have been diagnosed with atrial fibrillation or flutter and are already taking one of these two medications.
Why is this trial significant?
This trial matters because it will provide crucial data on the comparative safety and effectiveness of two widely used blood thinners, helping to optimize stroke prevention for veterans with atrial fi
What are the potential risks of participating in NCT06953726?
The main risks include bleeding, which can range from minor bruising to severe internal bleeding. Other potential side effects include stroke, systemic embolism (blood clots traveling to other parts of the body), and death. Specific side effects related to apixaban or rivaroxaban may also occur, such as nausea, dizziness, or allergic reactions. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06953726?
Ask your doctor if you are eligible and what the potential benefits and risks are for you. Understand that you will be randomly assigned to continue one of the two medications, and your health information will be gathered from your VA electronic medical records. Be prepared for regular check-ins and to report any new symptoms or side effects to your healthcare team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06953726 signal from an investment perspective?
This large-scale, 7-year trial involving 10,000 patients signals a significant investment in understanding standard-of-care treatments, with high approval probability for findings that refine current This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves being randomly assigned to continue taking either apixaban or rivaroxaban, with data collected from electronic health records. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.