Clinical trial NCT04476147: The Impact of Frailty on Thrombosis of Elderly Patients With NVAF （FTE-NVAF）
Official title: The Impact of Frailty on Thrombosis of Elderly Patients With Non-valvular Atrial Fibrillation (NVAF).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-valvular Atrial Fibrillation, Elderly, Frailty, Thrombosis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The inhospital patients (≥65yr) with NVAF of Beijing Friendship Hospital, Capital Medical University

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* ≥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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Ischemic stroke
timeFrame: 24 months
measure: Massive hemorrhage
timeFrame: 24 months
measure: All-cause death
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
Study officials:
affiliation: Beijing Friendship Hospital
name: Yunli Xing, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Xing 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.
citation: Fumagalli 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.
citation: Bo 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.
citation: Mazzone 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.