NCT03524924|CompletedDMC
Edoxaban and Frailty in Senior Individuals
ESCAPE
Edoxaban Performance in Senior Citizen With Non-valvular Atrial Fibrillation Evaluated Per Frailty
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ESCAPE
Edoxaban Performance in Senior Citizen With Non-valvular Atrial Fibrillation Evaluated Per Frailty
Sponsor study identifier
observational
180
1 country
1
Study Start
January 7, 2018
Actual (reported)Primary Completion
January 14, 2021
Actual (reported)Study Completion
March 31, 2021
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 7, 2018
Actual (reported)April 26, 2018
Actual (reported)May 15, 2018
Actual (reported)January 14, 2021
Actual (reported)March 31, 2021
Actual (reported)Cumulative incidence of arterial ischemic events, major bleeding, and clinically relevant non-major bleeding
Cumulative incidence of arterial ischemic events (stroke/TIA and systemic embolism), major bleeding according to ISTH definition, and clinically relevant non-major bleeding (bleeding not meeting major bleeding criteria but considered clinically significant).
Through study completion, an average of 24 months
Death
Divided into cardiovascular death, fatal bleeding and other causes of death
Through study completion, an average of 24 months
Correlation of frailty, as measured with Survey of Health, Ageing and Retirement in Europe - Frailty Instrument, with the cumulative incidence of stroke/TIA, systemic embolism, major bleeding and clinically relevant non-major bleeding.
24 months
Death
Through study completion, an average of 24 months
Survey of Health, Ageing and Retirement in Europe Frailty Instrument (SHARE-FI) score Female: \< 0.3151361243 Male: \< 1.211878526
Survey of Health, Ageing and Retirement in Europe Frailty Instrument (SHARE-FI) score Female: 0.3151361243 to \< 2.1301121973 Male: 1.211878526 to \< 3.0052612772
Survey of Health, Ageing and Retirement in Europe Frailty Instrument (SHARE-FI) score Female: 2.1301121973 to \< 6 Male: 3.0052612772 to \< 7
This is an observational prospective cohort study including patients with a new diagnosis of NVAF.
Padua University Hospital
Padova, 35100, Italy
Denas G, Zoppellaro G, Granziera S, Pagliani L, Noventa F, Iliceto S, Pengo V. Very Elderly Patients With Atrial Fibrillation Treated With Edoxaban: Impact of Frailty on Outcomes. JACC Adv. 2023 Aug 24;2(7):100569. doi: 10.1016/j.jacadv.2023.100569. eCollection 2023 Sep.
Vittorio Pengo, Prof
Padua University Hospital
180 participants (actual enrollment reported by the registry).
First Submitted
April 26, 2018
First Posted
May 15, 2018
Study Start
January 7, 2018
Actual (reported)Early Identification of Warfarin Maintenance Dosage
Contact the study team to confirm eligibility.
Primary Completion
January 14, 2021
Actual (reported)Study Completion
March 31, 2021
Actual (reported)Last Updated
August 10, 2022
Record last verified: 2022-08
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Source: ClinicalTrials.gov.
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