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

Phase 1

Active, not recruiting

• Conditions: ew Atrial Fibrillation patients; Atrial Fibrillation; SAMe-TT2R2 score; Intensive educational intervention; Anticoagulation therapy; The time in therapeutic range

• Registration Number: TCTR20180711003
• Lead Sponsor: Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-11
• Study Completion: 2022-11-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Patient must meet all of the following inclusion criteria to be eligible for study:
(1) More than 18 years of age
(2) Newly diagnosed non-valvular AF patients
(3) ECG-documented AF
(4) Warfarin-eligible (men with CHA2DS2VASc score more than1; women with CHA2DS2VASc score more than 2)
(5) Warfarin-naive (No treatment with warfarin within the past 12 months, treatment may have started within the prior 28 days from randomisation
(6) Able to comply with scheduled visits, treatment plan and laboratory tests
(7) Able to give informed consent and comply with study protocol (with support of a carer)

Exclusion Criteria

The subjects present with the following criteria will not be included:
(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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time in the Therapeutic Range (TTR) 12 month INR level

Secondary Outcome Measures

Name	Time	Method
Time in the Therapeutic Range (TTR) 6 month INR level,Thromboembolic and bleeding events 12 month Number of thromboembolic and bleeding events,major adverse cardiovascular events (MACE) 12 month Number of major adverse cardiovascular events (MACE),Atrial Fibrillation Knowledge 6 and 12 month Questionnaires,Economic: Cost Effectiveness 6 and 12 month Questionnaires,Economic: Quality of life 6 and 12 month EQ5D5L questionnaires,Qualitative: Patient Satisfaction 6 month Patient interview analyse by frame matrices