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 research grant:
- 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 research grant include clinical trials or real-world evidence studies that aim to advance the clinical practice knowledge of apixaban in patients with nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE; for treatment or recurrence prevention), including patient populations such as the following:
- Body mass index >40 kg/m2 and/or weight >120 kg.
- Weight ≤60 kg.
- Ethnic/race groups such as African–American, Asian, Hispanic etc.
- Treatment discontinuations/continuation after bleeding events (particularly gastrointestinal).
- Outcomes of anticoagulation treatment in NVAF after 1 year.
- Adherence to therapy/treatment persistence.
- Transitions of care in VTE.
- Secondary prevention of VTE in hematologic malignancies.
Non-eligible areas of research
Areas of research NOT eligible for an ARISTA-USA research grant include clinical trials and real-world evidence 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, including non-approved US apixaban dosing regimens.
- Pregnant and lactating women.
- Repeat/duplication of research, including studies listed for apixaban in ClinTrials.gov, and any Phase 3 trials, including ARISTOTLE, AVERROES, AMPLIFY & AMPLIFY-EXT.
- Any head-to-head comparison of apixaban versus dabigatran or rivaroxaban or edoxaban (or another direct oral anticoagulant).
- Research involving andexanet alfa.
- Certain special populations:
- Patients with NVAF and heart failure, coronary artery disease (including acute coronary syndrome and percutaneous coronary intervention), stroke and transient ischemic attack.
- Patients with intracranial hemorrhage.
- Patients with end stage renal disease and on hemodialysis.
- Patients with cancers other than hematological malignancies.
- Pharmacokinetics or pharmacokinetics/pharmacodynamics, including studies with crushed tablets, in hemodialysis, peritoneal dialysis, plasmapheresis, in special patient populations etc.
- Studies that focus on periprocedural use or use of apixaban in patients with devices:
- Post coronary artery bypass graft.
- Mechanical heart valves.
- Watchman device.
- Left ventricular assist device.
- Catheter ablation.
- Data in patients with breakthrough thrombosis while on anticoagulation.
- Home treatment of patients with VTE diagnosed in the emergency department.
- Upper extremity and lower distal extremity (calf) deep vein thrombosis.