Non-valvular Atrial Fibrillation, Elderly, Frailty, ThrombosisNCT04476147
The Impact of Frailty on Thrombosis of Elderly Patients With NVAF （FTE-NVAF）
An observational study of Non-valvular Atrial Fibrillation, Elderly, Frailty, Thrombosis, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This study aims to investigate the use of anticoagulants in elderly patients with non-valvular atrial fibrillation (NVAF) and the incidence of frailty in elderly patients with NVAF. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation, Elderly, Frailty, Thrombosis
- What is being tested?
- Diagnostic Test: CHA2DS2-VASc, HAS-BLED and Fried Scale.
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Mar 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The inhospital patients (≥65yr) with NVAF of Beijing Friendship Hospital, Capital Medical University
Who may be able to join
- ≥65yr
- Confirmed non-valvular atrial fibrillation (NVAF) diagnosis with ECG or Holter
- fulfilled CHA2DS2-VASc, HAS-BLED and Fried Scale
- patients agreed and provided informed consent
Who cannot join
- valvular atrial fibrillation
- cardiac surgery related atrial fibrillation
- acute disease related atrial fibrillation
- patients not fulfilled all the exam and text，or not accept the follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
Hongwei Li, 0086 10 63139780, lhw19656@sina.com
Xuhe Gong, 0086 10 63139780, gongxuhe123@126.com
About this study
Official title: The Impact of Frailty on Thrombosis of Elderly Patients With Non-valvular Atrial Fibrillation (NVAF).
This study aims to investigate the use of anticoagulants in elderly patients with non-valvular atrial fibrillation (NVAF) and the incidence of frailty in elderly patients with NVAF. After two years follow-up, we observe the incidence of thrombotic events and the influence of frailty on thrombotic events in elderly patients with NVAF.
- Being tested
- Diagnostic Test: CHA2DS2-VASc, HAS-BLED and Fried Scale.
- Medical subject headings
- Frailty, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: CHA2DS2-VASc, HAS-BLED and Fried Scale.Other
This is an observational study. All the patients evaluate with CHA2DS2-VASc, HAS-BLED and Fried Scale, and observe the incidence of thrombotic events and the influence of frailty on thrombotic events in elderly patients with NVAF.
| Study group | Role | What they receive |
|---|---|---|
| Participates | This is an observational study Receives: Other: Diagnostic Test: CHA2DS2-VASc, HAS-BLED and Fried Scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic stroke
Cerebral infarction, Transient ischemic attack, Cerebral embolism.
Measured: 24 months
Massive hemorrhage
Life-threatening or imminently fatal bleeding, intracranial, retroperitoneal, compartment syndrome, massive gastrointestinal, etc.
Measured: 24 months
All-cause death
All-cause death during the 2-year observation
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-valvular Atrial Fibrillation, Elderly, Frailty, ThrombosisStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Li, MD, Beijing Friendship Hospital
- Investigators
- Yunli Xing, Dr., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476147
- Sponsor's protocol ID
- BFH - Frailty and thrombosis
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xing Y, Ma Q, Ma X, Wang C, Zhang D, Sun Y. CHADS2 score has a better predictive value than CHA2DS2-VASc score in elderly patients with atrial fibrillation. Clin Interv Aging. 2016 Jul 14;11:941-6. doi: 10.2147/CIA.S105360. eCollection 2016.
PubMed 27478371Xing YL, Ma Q, Ma XY, Wang CY, Zhou Z, Huang YS, Sun Y. Characteristics of non-valvular atrial fibrillation patients who benefit most from anticoagulation treatment. Int J Clin Exp Med. 2015 Oct 15;8(10):18721-8. eCollection 2015.
PubMed 26770487Fumagalli S, Said SAM, Laroche C, Gabbai D, Marchionni N, Boriani G, Maggioni AP, Popescu MI, Rasmussen LH, Crijns HJGM, Lip GYH; EORP-AF Investigators. Age-Related Differences in Presentation, Treatment, and Outcome of Patients With Atrial Fibrillation in Europe: The EORP-AF General Pilot Registry (EURObservational Research Programme-Atrial Fibrillation). JACC Clin Electrophysiol. 2015 Aug;1(4):326-334. doi: 10.1016/j.jacep.2015.02.019. Epub 2015 Apr 20.
PubMed 29759321Bo M, Li Puma F, Badinella Martini M, Falcone Y, Iacovino M, Grisoglio E, Bonetto M, Isaia G, Ciccone G, Isaia GC, Gaita F. Health status, geriatric syndromes and prescription of oral anticoagulant therapy in elderly medical in-patients with atrial fibrillation: a prospective observational study. Int J Cardiol. 2015;187:123-5. doi: 10.1016/j.ijcard.2015.03.334. Epub 2015 Mar 21. No abstract available.
PubMed 25828331Mazzone A, Bo M, Lucenti A, Galimberti S, Bellelli G, Annoni G. The role of comprehensive geriatric assessment and functional status in evaluating the patterns of antithrombotic use among older people with atrial fibrillation. Arch Gerontol Geriatr. 2016 Jul-Aug;65:248-54. doi: 10.1016/j.archger.2016.04.008. Epub 2016 Apr 13.
PubMed 27131228
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Frailty on Thrombosis of Elderly Patients With Non-valvular Atrial Fibrillation (NVAF).
- ClinicalTrials.gov ID
- NCT04476147
- Acronym / sponsor ID
- BFH - Frailty and thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 17 Jul 2020 (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.
This study aims to investigate the use of anticoagulants in elderly patients with non-valvular atrial fibrillation (NVAF) and the incidence of frailty in elderly patients with NVAF. After two years follow-up, we observe the incidence of thrombotic events and the influence of frailty on thrombotic events in elderly patients with NVAF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participates | – | Other: Diagnostic Test: CHA2DS2-VASc, HAS-BLED and Fried Scale.This is an observational study |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The inhospital patients (≥65yr) with NVAF of Beijing Friendship Hospital, Capital Medical University
Key inclusion criteria (4 listed)
- ≥65yr
- Confirmed non-valvular atrial fibrillation (NVAF) diagnosis with ECG or Holter
- fulfilled CHA2DS2-VASc, HAS-BLED and Fried Scale
- patients agreed and provided informed consent
Key exclusion criteria (4 listed)
- valvular atrial fibrillation
- cardiac surgery related atrial fibrillation
- acute disease related atrial fibrillation
- patients not fulfilled all the exam and text，or not accept the follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: CHA2DS2-VASc, HAS-BLED and Fried Scale.This is an observational study. All the patients evaluate with CHA2DS2-VASc, HAS-BLED and Fried Scale, and observe the incidence of thrombotic events and the influence of frailty on thrombotic events in elderly patients with NVAF. | Other | Participates |
Primary outcome
Ischemic stroke
Time frame: 24 months
Cerebral infarction, Transient ischemic attack, Cerebral embolism.
Massive hemorrhage
Time frame: 24 months
Life-threatening or imminently fatal bleeding, intracranial, retroperitoneal, compartment syndrome, massive gastrointestinal, etc.
All-cause death
Time frame: 24 months
All-cause death during the 2-year observation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Background: PubMed 27478371Xing Y, Ma Q, Ma X, Wang C, Zhang D, Sun Y. CHADS2 score has a better predictive value than CHA2DS2-VASc score in elderly patients with atrial fibrillation. Clin Interv Aging. 2016 Jul 14;11:941-6. doi: 10.2147/CIA.S105360. eCollection 2016.
- Background: PubMed 26770487Xing YL, Ma Q, Ma XY, Wang CY, Zhou Z, Huang YS, Sun Y. Characteristics of non-valvular atrial fibrillation patients who benefit most from anticoagulation treatment. Int J Clin Exp Med. 2015 Oct 15;8(10):18721-8. eCollection 2015.
- Background: PubMed 29759321Fumagalli S, Said SAM, Laroche C, Gabbai D, Marchionni N, Boriani G, Maggioni AP, Popescu MI, Rasmussen LH, Crijns HJGM, Lip GYH; EORP-AF Investigators. Age-Related Differences in Presentation, Treatment, and Outcome of Patients With Atrial Fibrillation in Europe: The EORP-AF General Pilot Registry (EURObservational Research Programme-Atrial Fibrillation). JACC Clin Electrophysiol. 2015 Aug;1(4):326-334. doi: 10.1016/j.jacep.2015.02.019. Epub 2015 Apr 20.
- Background: PubMed 25828331Bo M, Li Puma F, Badinella Martini M, Falcone Y, Iacovino M, Grisoglio E, Bonetto M, Isaia G, Ciccone G, Isaia GC, Gaita F. Health status, geriatric syndromes and prescription of oral anticoagulant therapy in elderly medical in-patients with atrial fibrillation: a prospective observational study. Int J Cardiol. 2015;187:123-5. doi: 10.1016/j.ijcard.2015.03.334. Epub 2015 Mar 21. No abstract available.
- Background: PubMed 27131228Mazzone A, Bo M, Lucenti A, Galimberti S, Bellelli G, Annoni G. The role of comprehensive geriatric assessment and functional status in evaluating the patterns of antithrombotic use among older people with atrial fibrillation. Arch Gerontol Geriatr. 2016 Jul-Aug;65:248-54. doi: 10.1016/j.archger.2016.04.008. Epub 2016 Apr 13.
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.
Yunli Xing, Dr. principal investigator
Beijing Friendship 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 Non-valvular Atrial Fibrillation, Elderly, Frailty, Thrombosis, run by Beijing Friendship Hospital at 1 site in China.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Jul 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongwei Li, Prof. (0086 10 63139780, lhw19656@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic stroke (time frame: 24 months). The study lists 3 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 NCT04476147, which also lists 5 linked publications.
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 17 Jul 2020.