Atrial FibrillationESCAPENCT03524924
Edoxaban and Frailty in Senior Individuals
An observational study of Atrial Fibrillation, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2018to 31 Mar 2021
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: This is an observational prospective cohort study including patients with a new diagnosis of NVAF.
Who may be able to join
- NVAF diagnosed in the past 30 days
- Age at baseline of 80 years or older with indication for anticoagulation treatment with edoxaban
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Edoxaban Performance in Senior Citizen With Non-valvular Atrial Fibrillation Evaluated Per Frailty
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).
Read the 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
- Keywords
- atrial fibrillation, elderly, edoxaban, frailty, SHARE-FI, Stroke, Major bleeding
- Medical subject headings
- Atrial Fibrillation, Frailty, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 24 months
Death
Divided into cardiovascular death, fatal bleeding and other causes of death
Measured: 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.
Patients will be divided into 3 groups according to frailty measured with Survey of Health, Ageing and Retirement in Europe - Frailty Instrument (SHARE-FI) which provides 3 patient categories (non-frail, pre-frail and frail).
A score of < 0.3151361243 defines non frail female patients; a score of 0.3151361243 to 2.1301121973 defines pre-frail female patients; a score of 2.1301121973 to 6 defines frail female patients.
A score of < 1.211878526 defines non frail male patients; a score of 1.211878526 to 3.0052612772 defines pre-frail male patients; a score of 3.0052612772 to 7 defines frail male patients.
Further SHARE-FI score details and calculations are available at: https://sites.google.com/a/tcd.ie/share-frailty-instrument-calculators/.
Outcome events will be compared among the three groups.
Measured: 24 months
Death
All cause mortality
Measured: Through study completion, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start7 Jan 2018
- Primary completion14 Jan 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vittorio Pengo, University of Padova
- Investigators
- Vittorio Pengo, Prof, Principal investigator, Padua University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524924
- Sponsor's protocol ID
- 4291/AO/17
- Acronym
- ESCAPE
- Status last verified
- Aug 2022
- First submitted
- 26 Apr 2018
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38939480
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edoxaban Performance in Senior Citizen With Non-valvular Atrial Fibrillation Evaluated Per Frailty
- ClinicalTrials.gov ID
- NCT03524924
- Acronym / sponsor ID
- ESCAPE / 4291/AO/17
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, elderly, edoxaban, frailty, SHARE-FI, Stroke, Major bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 15 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This is an observational prospective cohort study including patients with a new diagnosis of NVAF.
Key inclusion criteria (2 listed)
- NVAF diagnosed in the past 30 days
- Age at baseline of 80 years or older with indication for anticoagulation treatment with edoxaban
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative incidence of arterial ischemic events, major bleeding, and clinically relevant non-major bleeding
Time frame: Through study completion, an average of 24 months
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).
Death
Time frame: Through study completion, an average of 24 months
Divided into cardiovascular death, fatal bleeding and other causes of death
2 secondary outcomes
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.
Time frame: 24 months
Death
Time frame: Through study completion, an average of 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Derived from this study: PubMed 38939480Denas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vittorio Pengo, Prof principal investigator
Padua University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of arterial ischemic events, major bleeding, and clinically relevant non-major bleeding (time frame: Through study completion, an average of 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03524924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.