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.
- Assessment and use of apixaban in special populations with nonvalvular AF (NVAF) such as:
- Body mass index (BMI) >40 kg/m2 and/or weight >120 kg.
- Weight ≤60 kg.
- Impaired renal function.
- Assessment of apixaban in acute diagnosis and early emergency department discharge in NVAF.
- Switching oral anticoagulants (OACs) in patients with NVAF with emphasis on switching from vitamin K antagonist (VKA) therapy to apixaban.
- How to improve the identification, detection, and diagnosis of NVAF.
- Use in NVAF managing atrial and apical akinesis or dyskinesis.
- Practical use of anticoagulation with apixaban for reducing the risk of stroke in patients who develop NVAF after cancer surgery and/or treatment in patients with active cancer or with history of cancer.
- Practical use of apixaban in initial, long-term and extended deep vein thrombosis (DVT)/pulmonary embolism (PE) treatment.
- Assessment and use of apixaban in special populations with venous thromboembolism (VTE):
- BMI >40 kg/m2and/or weight >120 kg.
- Impaired renal function.
- Use of apixaban in patients with provoked VTE (initial and extended).
- Bleeding management related to the use of apixaban.
- Practical use of apixaban in patients with hypercoagulable diseases.
- Real-World data analysis on OACs/apixaban use within the eligible areas.
- 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), including non-approved US apixaban dosing regimens.
- Pregnant and lactating women.
- 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.
- Assessment of apixaban in patients with the combination of any of the following: heart failure (HF), NVAF, coronary artery disease (CAD).
- Pharmacokinetic (PK) or PK/pharmacodynamic (PD) study of any kind, including studies with crushed tablets, in hemodialysis, peritoneal dialysis, plasmapheresis, in special patient populations etc.
- 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.
- Any randomized clinical trial evaluating the safety of apixaban in patients with end-stage renal disease (ESRD) on hemodialysis.
- Efficacy of apixaban in secondary prevention of transient ischemic attack (TIA)/cardiovascular accident (CVA).
- Apixaban use with Watchman device.
- Assessment of apixaban in patients with cryptogenic stroke.
- Transcatheter aortic valve replacement (TAVR) and treatment of subclinical leaflet thrombosis in patients with TAVR and AF.
- Use of apixaban in patients with left ventricular assist device (LVAD).
- Drug–drug interaction studies.
- VTE prophylaxis with apixaban in patients with glioblastoma.
- VTE treatment or prevention in general cancer patients.
- Use of apixaban after intracranial hemorrhage.
- Use, safety, and efficacy of apixaban as periprocedural anticoagulant for catheter ablation of AF.
- Upper extremity and lower distal extremity (calf) DVT.
- Research involving andexanet alfa.