Condition category
Circulatory System
Date applied
19/11/2020
Date assigned
03/12/2020
Last edited
27/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Anticoagulants ('blood thinners') are needed to prevent stroke and death in patients with atrial fibrillation (AF). AF is the world's most common form of irregular heartbeat, including in Thailand. Anticoagulation is a mainstay treatment in AF patients to prevent strokes. Warfarin is the most commonly used anticoagulant in Thailand, but because it is influenced by many diet and patient factors it can be difficult to achieve good anticoagulation control. In Thailand, because of this, most patients receive inadequate control of their anticoagulation when using warfarin, leading to increased risk of stroke and death.
The aim of this study is to conduct a study in Thai AF patients who have not used an anticoagulant before to evaluate the use of a simple clinical prediction score (SAMe-TT2R2) to help identify those patients likely to have a good response to anticoagulation with warfarin, compared with usual care. Depending on the score participants will be given an educational-behavioural intervention as an addition to their routine care to improve their time in therapeutic range (TTR) on warfarin.

Who can participate?
Men and women aged 18 and over who have been newly diagnosed with non-valvular AF

What does the study involve?
Participants will attend five hospital visits throughout the duration of the study. Each visit will take about 30 minutes and involve physical examinations, blood tests and clinical assessments. Participants will be asked to provide their personal information, medical history and medications they are currently taking. They will be asked to complete a series of questionnaires to measure their life quality and the expenses for medical treatment that they pay for. Participants will also be offered to take part in a sub-study exploring patient satisfaction and acceptance of the TREATS intervention approach.
Eligible participants will be randomly allocated into one of two groups. One group will continue to receive their current usual care; the other group will also continue to receive usual care but also have the extra education (the TREAT intervention) given to them. The intervention group will be provided with additional information on how to use warfarin effectively. This will be carried out by face-to-face discussion, viewing a video and receiving a booklet. The duration of this activity will take about 30 minutes.

What are the possible benefits and risks of participating?
Participants may not directly benefit from their participation in this study. However, the information from this study could further benefit patients with atrial fibrillation who are treated with Warfarin. There are no additional risks involved over those of standard care.

Where is the study run from?
Chiang Mai University (Thailand)

Who is funding the study?
1. Medical Research Council (UK)
2. National Research Council of Thailand (Thailand)
3. Newton Fund (UK)

Who is the main contact?
Sukhi Sehmi
s.sehmi@bham.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Prof Arintaya Phrommintikul

ORCID ID

http://orcid.org/0000-0003-3986-1951

Contact details

Department of Internal Medicine
Faculty of Medicine
Chiang Mai University
Muang Chiang Mai
Chiang Mai
50200
Thailand
+66 (0)5393 6793
arintaya.p@cmu.ac.th

Type

Scientific

Additional contact

Prof Gregory Lip

ORCID ID

http://orcid.org/0000-0002-7566-1626

Contact details

Liverpool Centre for Cardiovascular Science
University of Liverpool
William Henry Duncan Building
6 West Derby Street
Liverpool
L7 8TX
United Kingdom
+44 (0)151 794 9020
gregory.lip@liverpool.ac.uk

Type

Scientific

Additional contact

Ms Sukhi Sehmi

ORCID ID

Contact details

Senior Trial Manager
Birmingham Clinical Trials Unit
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 415 8445
treatsaf@trials.bham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

TCTR20180711003, MR/R020892/1, DBG6180009

Study information

Scientific title

A prospective randomised trial examining the impact of an intensive educational intervention versus usual care on anticoagulation therapy control intervention based on SAMe-TT2R2 score guided strategy in anticoagulant-naïve Thai patients with atrial fibrillation (TREATS-AF)

Acronym

TREATS-AF

Study hypothesis

Primary hypotheses:
The SAMe-TT2R2 score guided strategy and educational intervention group have more time in the therapeutic range at 12 months than the usual care group.

Secondary hypotheses:
1. The SAMe-TT2R2 score guided strategy and educational intervention group have more time in the therapeutic range at 6 months than the usual care group.
2. The number of thromboembolic and bleeding events in The SAMe-TT2R2 score guided strategy of educational intervention group is less than the usual care group.
3. The number of major adverse cardiovascular events (MACE) in the SAMe-TT2R2 score guided strategy of educational intervention group is less than the usual care group.
4. The SAMe-TT2R2 score guided strategy of educational intervention group have better AF knowledge than the usual care group.

Ethics approval

Approved 08/01/2020, Central Research Ethics Committee (CREC) (5th Fl Building 2, The National Research Council of Thailand Paholyothin Rd., Bangkhen, Bangkok 10900, Thailand; +66 (0)2 579 0117; crec_thailand@hotmail.com), ref: CREC053/62BPm

Study design

Multicenter open-label randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

Patients diagnosed with new-onset, non-valvular atrial fibrillation and warfarin naïve

Intervention

The aim is to conduct a randomised-controlled trial (RCT) in Thai AF patients who have not used an anticoagulant before to evaluate the use of a simple clinical prediction score (SAMe-TT2R2) to help identify those patients likely to have a good response to anticoagulation with warfarin, compared with usual care. Predicted poorer responders (SAMe-TT2R2 >2) will be given an educational-behavioural intervention based on our previous RCT (TREAT trial) as an addition to routine care to improve their TTR on warfarin.

Method: Open-label RCT; 9-month recruitment period, 12-months follow-up.

Randomization will be done using a web-based platform with blinded allocation. Randomization will be stratified based on centre, sex (male or female) and baseline SAMe-TT2R2 score (0-2, 3-5, 6-8).

Eligible participants will be randomized to one of two groups: usual care vs SAMe-TT2R2 score-guided warfarin (i.e. score 0-2: usual care alone; score >2: usual care plus TREAT educational-behavioural intervention as an adjunct to their regular INR monitoring to improve their TTR on warfarin).

Participants will attend five hospital visits throughout the duration of the study. Each visit will take approximately 30 minutes and involve physical examinations, blood tests and clinical assessments.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Time in the Therapeutic Range (TTR) measured by INR level at 12 months

Secondary outcome measures

1. Time in the Therapeutic Range (TTR) measured by INR level at 6 months
2. Patients’ knowledge measured by the atrial fibrillation knowledge scale questionnaire at baseline, 6 and 12 months
3. Quality of life measured by the EQ-5D-5L questionnaire at baseline, 6 and 12 months
4. Cost-effectiveness measured by CRF questionnaire at 6 and 12 months
5. Cardiovascular event measured by the number of events recorded at 12 months

Overall trial start date

01/04/2018

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Newly diagnosed AF patients
2. Adults (aged ≥18 years) with ECG-documented non-valvular AF and ≥1 stroke risk factor (based on CHA2DS2VASc score)
3. Warfarin-eligible patients (men with CHA2DS2VASc score ≥1; women with CHA2DS2VASc score ≥2) who are warfarin-naïve (having never taken warfarin) will be considered for inclusion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

320

Participant exclusion criteria

1. Any contraindication to oral anticoagulants
2. Prosthetic cardiac valve or significant valvular heart disease with an indication for heart surgery
3. Likelihood of intermittent or permanent discontinuation of warfarin during follow up, e.g. major surgery or post AF ablation
4. Known active malignancy
5. Diagnosed cognitive impairment
6. Any disease likely to cause death within 12 months
7. Unable to provide written informed consent

Recruitment start date

31/01/2020

Recruitment end date

31/05/2021

Locations

Countries of recruitment

Thailand

Trial participating centre

Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
50200
Thailand

Trial participating centre

ChiangRai Prachanukroh Hospital
Chiang Rai
57000
Thailand

Trial participating centre

Nakornping Hospital
Chiang Mai
50180
Thailand

Trial participating centre

Lampang Hospital
Lampang
52100
Thailand

Trial participating centre

Siriraj Hospital
Bangkok
10700
Thailand

Trial participating centre

Maharat Nakhon Ratchasima Hospital
Nakhon Ratchasima
30000
Thailand

Trial participating centre

Queen Sirikit Heart Center of the Northeast and Srinagarind Hospital
Khon Kaen
40002
Thailand

Sponsor information

Organisation

Chiang Mai University

Sponsor details

Faculty of Medicine
Muang Chiang Mai
Chiang Mai
50200
Thailand
+66 (0)5393 6209
researchmed@cmu.ac.th

Sponsor type

University/education

Website

https://www.med.cmu.ac.th/

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

National Research Council of Thailand

Alternative name(s)

NRCT

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Thailand

Funder name

Newton Fund

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. No additional documents are available.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Thailand Chief Investigator Arintaya Phrommintikul (arintayap@gmail.com).

Intention to publish date

30/12/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

27/11/2020: Trial's existence confirmed by Central Research Ethics Committee (CREC).