Project

GLORIA -AF

Completed · 2014 until 2019

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2014
End Date
2019
Financing
Industry
Study Design
International, multicenter, prospective observational study (registry)
Partner
Universitätsspital Basel, Neurologische Universitätsklinik, Petersgraben 4, CH-4031 Basel
Brief description/objective

GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment in Patients with Atrial Fibrillation (Phase II/III – India and Switzerland)
International, multicenter, prospective observational study for patients with newly diagnosed non-valvular atrial fibrillation.The Registry Program will be run in three different phases. Phase I is conducted before approval of dabigatran. This protocol describes the two phases after dabigatran is approved for preventing strokes in patients with atrial fibrillation (SPAF) in participating countries (Phases II and III) The phases differ regarding the handling of the follow-up period. In Phase II (after the approval of dabigatran) there will be a cross-sectional analysis at the patient’s baseline visit for all patients and a follow-up for two years for patients initially treated with dabigatran. In Phase III (given the comparability of the patient population prescribed either dabigatran or vitamin K-antagonists) new patient recruitment will be started and after
the baseline visit all patients will be followed up for three years regardless of antithrombotic therapy treatment status.
Patients will either participate in Phase II or Phase III.