NCT03524924

Edoxaban and Frailty in Senior Individuals

Edoxaban Performance in Senior Citizen With Non-valvular Atrial Fibrillation Evaluated Per Frailty

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 180 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

Edoxaban, has shown in clinical registration trials a significant reduction of major bleeding compared to warfarin, especially in elderly patients. Efficacy and safety of edoxaban will be assessed in a cohort of very elderly patients (≥80 years of age) with NVAF. A secondary analysis will correlate outcomes with frailty defined according to SHARE-FI (not-frail, pre-frail or frail).

Detailed description

Aim of the study To assess the efficacy and safety of edoxaban in a cohort of very elderly patients (≥80 years of age) with NVAF. Edoxaban has never been tested in elderly frail patients. In both sexes, there is a non-linear association between age and frailty. A secondary analysis according to frailty assessment (not-frail, pre-frail or frail) will be also performed. Study Design Observational prospective cohort study including patients of ≥80 years of age with a new diagnosis of NVAF. Edoxaban 60 mg (or 30 mg for patients with CrCL 15 - 50 mL/min or with body weight ≤ 60 kg) will be administered to all patients. All participants will be stratified according to frailty, as assessed by SHARE-FI score, to non-frail, pre-frail, and frail. Study Population Patients of both sexes, of ≥80 years of age with a new diagnosis of non-valvular atrial fibrillation and without contraindications to Edoxaban. Outcomes The following events will be included as outcomes: * arterial ischemic events (TIA or stroke documented a CT scan; documented systemic embolism) * major bleeding events (according to the ISTH definition) * clinically relevant non-major bleeding (CRNM), defined as bleeding that did not meet the definition of major bleeding, but considered clinically significant (including spontaneous gastrointestinal bleeding or rectal bleeding; macroscopic haematuria or urethral bleeding requiring medical attention; skin haematoma \>25 cm2; and gingival bleeding or spontaneous ear-nose-throat bleeding lasting ≥5 min) and/or resulted in discontinuation of study medication18. * death (divided into cardiovascular death, fatal bleeding and other causes of death). Follow up Follow-up visits will be performed at 3, 6, 12 and 24 months to assess adherence and compliance to therapy, evaluation of relevant blood test and clinical assessment. Temporary discontinuation of edoxaban for a planned surgical intervention will be allowed. Patients will be followed until the occurrence of a first outcome event, permanent discontinuation of edoxaban or the end of follow-up period, whichever comes first.

Conditions

• Atrial Fibrillation

Timeline

• Start date: 2018-01-07
• Primary completion: 2021-01-14
• Completion: 2021-03-31
• First posted: 2018-05-15
• Last updated: 2022-08-10

Locations

1 site across 1 country: Italy