Prospective randomised trial examining the impact of an educational intervention versus usual care on anticoagulation therapy control based on an SAMe-TT


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
11 10 2021
Historique:
entrez: 12 10 2021
pubmed: 13 10 2021
medline: 4 11 2021
Statut: epublish

Résumé

The burden of atrial fibrillation (AF) in Thailand is high and associated with increased morbidity, mortality and healthcare costs. Vitamin K antagonists (eg, warfarin), commonly used for stroke prevention in patients with AF in Thailand, are effective but are often suboptimally controlled. We aim to evaluate the impact of an SAMe-TT Multicentre, open-label, parallel-group, randomised controlled trial conducted in Thailand among adult patients (age: 18 years) with AF who are anticoagulant naïve. Patients will be randomised to one of two groups; an SAMe-TT The study has been approved by the Ethical Review Committee, Ministry of Public Health of Thailand, and registered in the Thai Clinical Trials Registry. The results of this trial will be submitted for publication in a peer-reviewed journal. Participants will be informed via a link to a preview of the publication. A lay summary will also be provided to all participants prior to publication. TCTR20180711003.

Identifiants

pubmed: 34635526
pii: bmjopen-2021-051987
doi: 10.1136/bmjopen-2021-051987
pmc: PMC8506852
doi:

Substances chimiques

Anticoagulants 0

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e051987

Subventions

Organisme : Medical Research Council
ID : MR/R020892/1
Pays : United Kingdom

Investigateurs

Narawudt Prasertwitayakij (N)
Wattana Wongtheptien (W)
Thanyaluck Chotayaporn (T)
Natrawee Bureekam (N)
Bancha Sookananchai (B)
Vichai Senthong (V)
Antika Wongthanee (A)
Gemma Slinn (G)
Anita Slade (A)

Informations de copyright

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: All other authors have no actual or potential conflict of interest capable of influencing judgment on the part of any author on this work. AP and WW: reports speaker fees from Bayer, Pfizer, Boehringer Ingelheim, and Daiichi-Sankyo outside the submitted work. DL: reports investigator-initiated educational grants from Bristol-Myers Squibb (BMS); speaker fees for Boehringer Ingelheim, Bayer and BMS/Pfizer; and consultancy for BMS/Pfizer, Boehringer Ingelheim and Daiichi-Sankyo, all outside of the submitted work. GL: reports consultancy and speaker fees for BMS/Pfizer, Boehringer Ingelheim and Daiichi-Sankyo. No fees are received personally.

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Auteurs

Arintaya Phrommintikul (A)

Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Center for Medical Excellence, Faculty of Medicine, Chiang Mai, Thailand.

Surakit Nathisuwan (S)

Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.

Siriluck Gunaparn (S)

Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.

Rungroj Krittayaphong (R)

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.

Wanwarang Wongcharoen (W)

Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.

Sukhi Sehmi (S)

Clinical Trials Unit, University of Birmingham, Birmingham, UK.

Samir Mehta (S)

Clinical Trials Unit, University of Birmingham, Birmingham, UK.

Neil Winkles (N)

Clinical Trials Unit, University of Birmingham, Birmingham, UK.

Peter Brocklehurst (P)

Clinical Trials Unit, University of Birmingham, Birmingham, UK.

Jonathan Mathers (J)

Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Sue Jowett (S)

Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Kate Jolly (K)

Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Deirdre Lane (D)

Department of Cardiovascular Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.

G Neil Thomas (GN)

Department of Public Health and Epidemiology, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Gregory Y H Lip (GYH)

Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK Gregory.Lip@liverpool.ac.uk.
Department of Clinical Medicine, Aalborg Universitet, Aalborg, Denmark.

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