Edoxaban and Frailty in Senior Individuals

NCT03524924 | Completed DMC

• 1 other identifier: 4291/AO/17
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; elderly; edoxaban; frailty; SHARE-FI; Stroke; Major bleeding

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• 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

Study Arms (3)

non-frail

Survey of Health, Ageing and Retirement in Europe Frailty Instrument (SHARE-FI) score Female: \< 0.3151361243 Male: \< 1.211878526

pre-frail

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

frail

Survey of Health, Ageing and Retirement in Europe Frailty Instrument (SHARE-FI) score Female: 2.1301121973 to \< 6 Male: 3.0052612772 to \< 7

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is an observational prospective cohort study including patients with a new diagnosis of NVAF.

You may qualify if:

• NVAF diagnosed in the past 30 days
• Age at baseline of 80 years or older with indication for anticoagulation treatment with edoxaban

You may not qualify if:

• NVAF diagnosed more than 30 days prior to baseline visit
• Other OAT, except for warfarin or LMWH, already started at the time of baseline visit
• Patients with end stage renal disease (ESRD) (CrCL \< 15 mL/min) or on dialysis
• Severe hepatic impairment (defined as Child-Pugh Class B or C or increase in transaminases more than three times the upper reference value of normality) or hepatic disease associated with coagulopathy
• Elevated liver enzymes (ALT/AST \> 2 x ULN) or total bilirubin ≥ 1.5 x ULN at baseline
• Recent (within 1 month) or persisting gastrointestinal ulceration
• Active neoplasm
• Known or suspected oesophageal varices
• Arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
• Life expectancy \<1 year
• Concomitant use of strong P-gp drugs which contraindicate edoxaban use12 (e.g. HIV protease inhibitors)
• Clinically significant active bleeding or high risk of bleeding conditions such as: recent brain or spinal injury; recent brain, spinal or ophthalmic surgery; recent intracranial haemorrhage
• Known contraindications or hypersensitivity to the active substance or to any of the excipients of Lixiana
• Lack of acquisition of informed consent or refusal to participate by the subject or family representative

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Padua University Hospital

Padua, 35100, Italy

Location

Related Publications (1)

• 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.

  PMID: 38939480 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Frailty; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Vittorio Pengo, Prof

  Padua University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 15, 2018
• Study Start: January 7, 2018
• Primary Completion: January 14, 2021
• Study Completion: March 31, 2021
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

IT (1)