Non-valvular Atrial Fibrillation, Elderly, Frailty, Thrombosis Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | March 1, 2024 |
| Est. primary completion date | August 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Friendship Hospital, Capital Medical University | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Friendship Hospital |
China,
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. — View 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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ischemic stroke | Cerebral infarction, Transient ischemic attack, Cerebral embolism. | 24 months | |
| Primary | Massive hemorrhage | Life-threatening or imminently fatal bleeding, intracranial, retroperitoneal, compartment syndrome, massive gastrointestinal, etc. | 24 months | |
| Primary | All-cause death | All-cause death during the 2-year observation | 24 months |