Observational study in atrial fibrillation (AF) patients at high risk

• Research type

  Research Study

• Full title

  A Global prospective observationAl study of Real-worlD managemEnt of patieNts with atrIal fibrillAtion at high risk of stroke (GARDENIA)

• IRAS ID

  316317

• Contact name

  Ajay K. Kakkar

• Contact email

  akkakkar@tri-london.ac.uk

• Sponsor organisation

  Anthos Therapeutics

• Clinicaltrials.gov Identifier

  NCT05421533, ClinicalTrials.gov ID:

• Duration of Study in the UK

  3 years, 6 months, days

• Research summary

  Study purpose: to collect real-world clinical data on the utilization of oral anticoagulants in patients with Atrial Fibrillation (AF) at elevated risk of stroke. Patients with AF who meet 1 or more of the following criteria will be recruited: advanced age, renal dysfunction, the need for concomitant antiplatelet use, or otherwise judged to be at a higher risk of bleeding. Patients with these criteria are frequently not treated with currently approved oral anticoagulants or they are ‘undertreated’ based on the use of non-recommended doses of anticoagulants. These patients will be described with regards to baseline demographics and characteristics with particular attention focused on physician and patient factors that may play a role in the underuse of guideline-recommended anticoagulation therapy for stroke prevention in patients with AF. Patients in the registry will also be followed to determine the rates of discontinuation/switching of their anticoagulation therapy, incidence of major adverse cardiovascular events and clinically relevant outcome events related to the selection of their anticoagulation therapy.

  The collected real-world data will be used to inform future studies of patients with AF at elevated risk of stroke who are not treated with appropriate oral anticoagulant therapy.
  study objectives: • To evaluate the factors associated with the decision to treat or not treat patients with AF with guideline recommended doses of oral anticoagulants for stroke prevention
  • To evaluate the incidence of all bleeding events in patients with AF who are treated with guideline recommended doses of oral anticoagulants for stroke prevention versus those who are not
  • To evaluate the incidence of stroke and systemic embolic events in patients with AF who are treated with guideline recommended doses of oral anticoagulants for stroke prevention versus those who are not

• REC name

  Wales REC 6

• REC reference

  22/WA/0263

• Date of REC Opinion

  7 Oct 2022

• REC opinion

  Further Information Favourable Opinion