TREAT-2: Oral anticoagulation in AF stratified by SAMe-TT2R2 score
Research type
Research Study
Full title
An observational study of non-vitamin K antagonist oral anticoagulants (NOACs) versus warfarin based on the SAMe-TT2R2 score strata in anticoagulant-naive patients with atrial fibrillation: TREAT-2 study
IRAS ID
193145
Contact name
Hanis Zulkifly
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
1 years, 11 months, 4 days
Research summary
Good anticoagulation control is very important in atrial fibrillation (AF) patients taking oral anticoagulation ('blood-thinning' medication), usually warfarin. Anticoagulation control is measured by the International Normalised Ratio (INR)(a measure of blood clotting time) and for patients with atrial fibrillation this needs to be between 2.0-3.0. Time in this therapeutic range (TTR) needs to be 70% or more. Other anticoagulants are available (NOACs: apixaban, dabigatran, edoxaban, & rivaroxaban). The SAMe-TT2R2 score was developed to aid physicians to identify AF patients who would do well on warfarin and those who may need additional intervention to achieve good anticoagulation control. This project will seek to answer one of the research question posed by the NICE 2014 Atrial Fibrillation guidelines regarding newly diagnosed patients who have never taken an oral anticoagulant for whom poor warfarin control is predicted (using the SAMe-TT2R2 score) to be treated with warfarin or a NOAC. In addition, the study will examine the effect of an intensive one-off educational intervention on warfarin control at 6 months. Patients will be followed up for 6 months after being assigned to one of the four treatment groups based on their anticoagulant therapy initiated by their physician and their SAMe-TT2R2 score. Adult AF patients with ECG-documented non-valvular atrial fibrillation referred for anticoagulant therapy, with at least one additional risk factor for stroke (heart failure, hypertension, aged >65 years, diabetes, stroke/TIA/thromboembolism, vascular disease, female) will be eligible for inclusion. The primary outcome is time in the therapeutic range at 6 months for both groups commencing warfarin. Secondary endpoints are patients’ knowledge of AF, their beliefs about their medication, depression,anxiety and quality of life. Exploratory analyses will explore the incidence of minor and major bleeding, stroke, and thromboembolic events. All patients will receive questionnaire by post at baseline and 6-months after commencing anticoagulant therapy.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
16/WM/0339
Date of REC Opinion
26 Sep 2016
REC opinion
Further Information Favourable Opinion