Areas of Research Eligible for the Program
ARISTA-USA’s mission is to encourage the generation of new data to improve patient care for those requiring oral anticoagulation treatment, specifically with apixaban, in relevant disease areas for approved indications or areas of unmet medical needs or special interest.
The following types of studies (eligible areas of research, as defined below) will be considered for an ARISTA-USA award:
- Clinical studies involving non-pregnant, non-lactating adults age >18
- Outcomes research and/or epidemiological research (e.g. structured surveys, pharmacoeconomic studies, disease management initiatives etc.).
Eligible areas of research
Areas of research eligible for an ARISTA-USA award include studies that aim to advance the understanding of:
- Practical use of apixaban in specific situations and atrial fibrillation (AF)-related procedures
- Practical use of apixaban in initial, long-term and extended venous thromboembolism (VTE) treatment and VTE prevention
- Bleeding management related to the use of apixaban
- Practical use of anticoagulation with apixaban for reducing the risk of stroke in patients who develop nonvalvular AF (NVAF) after cancer surgery and/or treatment
- Practical use of apixaban in patients with hypercoagulable diseases
- Switching oral anticoagulants (OACs) in patients with NVAF with emphasis on switching from vitamin K antagonist (VKA) therapy to apixaban
- Practical use of apixaban in obese patients (body mass index ≥30 kg/m2)
- How to improve the identification, detection, and diagnosis of NVAF
- And providing Real-World data analysis on OACs/apixaban use
- Other potential areas of interest not included below.
Non-eligible areas of research
Areas of research NOT eligible for an ARISTA-USA award include studies of:
- Patient populations where the risk of apixaban use is greater than the benefit
- A use that is contraindicated in the apixaban United States product insert (USPI)
- Pregnant and lactating women
- A use of dosing regimens outside of the apixaban USPI
- Any head-to-head clinical trial comparison of apixaban versus dabigatran or rivaroxaban or edoxaban (or another direct OAC [DOAC])
- Repeat/duplication of research, including studies listed for apixaban in ClinTrials.gov (e.g. ablation, reversal or “acute” cardioversion)
- Repeat of any Phase 3 trials, including ARISTOTLE, AVERROES, AMPLIFY & AMPLIFY-EXT
- Any pharmacokinetic/pharmacodynamic properties described in the USPI, e.g. crushed tablets, hemodialysis
- Home treatment of patients with VTE diagnosed in the emergency department
- Reducing the recurrence of acute coronary syndrome (ACS), percutaneous coronary intervention (PCI)
- Post coronary artery bypass graft (CABG), prosthetic (mechanical and bioprosthetic heart valves or devices)
- Patients with any atherothrombotic or hemorrhagic stroke, or any stroke within 7 days
- VTE prophylaxis (VTEp) in patients with stroke and hemiparesis
- Evaluation of the safety of apixaban in patients with end-stage renal disease (ESRD) on hemodialysis
- Use of apixaban in chronic kidney disease
- Efficacy of apixaban in secondary prevention of transient ischemic attack (TIA)/cardiovascular accident (CVA).
- VTE treatment or prevention in general cancer patients
- Use of apixaban after intracranial hemorrhage
- Use, safety, and efficacy of apixaban as peri-procedural anti-coagulant for catheter ablation of AF
- Upper extremity deep vein thrombosis
- Research involving andexanet alfa.