New Atrial Fibrillation patients Atrial Fibrillation SAMe-TT2R2 score Intensive educational intervention Anticoagulation therapy The time in therapeutic range
Conditions
Interventions
The SAMe-
TT2R2 score was effective in predicting warfarin control whereby patients with a score>2 had poor control.,Usual care no other intervention.
SAMe-
TT2R2 score guided Oral anticoagulation (OAC),usual care
Sponsors
Faculty of Medicine, Chiang Mai University
The Thailand Research Fund
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time in the Therapeutic Range (TTR) 12 month INR level | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactArintaya Phrommintikul
Faculty of Medicine, Chiang Mai University
Outcome results
None listed