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ASPIRE EMRISTA | Areas of Interest

Studies that will be eligible for EMRISTA grants will include the ones which will aim to improve and advance:

The understanding of the use of non-vitamin K antagonist oral anticoagulants (NOACs) in atrial fibrillation (AF), including (but not limited to) the patient populations such as:
  • Elderly, fragile patients, patients with diabetes, symptomatic heart failure, hypertension, low body weight, renal impairment, prior stroke or transient ischemic attack (TIA) – excluding the acute/early phase of stroke treatment ie < 7days.
  • Pre- and/or post- surgical/invasive procedure use
  • Patients who are not well-controlled with Warfarin
  • Patients being switched from parenteral anticoagulants or Warfarin to NOACs
The identification, detection, and diagnosis of NVAF
Bleeding management related to the use of apixaban (with or without other anticoagulants)
Patient care and the translation of scientific evidence into clinical practice, such as:
  • Research aiming to improve patient adherence to therapy
  • Research to assess the impact of educational tools or multidisciplinary approaches to improve the use of NOACs and patient follow up, as evaluated by criteria like patient reported outcomes, patient satisfaction, patient preferences and quality of life
The understanding of the use of Apixaban (with or without other NOACs) in initial, long-term and extended venous thromboembolism (VTE) treatment and prevention
The understanding of the use of Apixaban (with or without other NOACs) in real-world clinical practice settings
Other potential areas of interest and unmet medical need not included above

Areas of research NOT eligible for EMRISTA grants include:

Any head-to-head clinical trial comparison of apixaban versus dabigatran or rivaroxaban or edoxaban (or another NOAC)
Any study involving NOACs other than Apixaban, but not Apixaban itself
Repeat/duplication of any Phase 3 trials, including ARISTOTLE, AVERROES, AMPLIFY & AMPLIFY-EXT
Studies related to any pharmacokinetic/pharmacodynamic properties already described in the label document, e.g. crushed tablets, hemodialysis
Studies in patient populations for which the risk of Apixaban use is greater than the benefit
Any indication/use that is contraindicated in the Apixaban label document
Any study using dosing regimens not approved in the Apixaban label document
Any study involving pregnant/lactating women and/or pediatric population
Research involving andexanet alfa
Reducing the recurrence of acute coronary syndrome (ACS), percutaneous coronary intervention (PCI)
Research involving patients with 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
Venous thromboembolism prophylaxis (VTEp) in patients with stroke and hemiparesis
Evaluation of the safety of Apixaban in patients with end-stage renal disease on hemodialysis
Efficacy of Apixaban in secondary prevention of TIA/cardiovascular accident (CVA)