Association between TTR-INR guided warfarin adjustment protocol and time in therapeutic range (TTR) in patients with atrial fibrillation receiving vitamin K antagonist oral anticoagulant
Phase 3
- Conditions
- Patient with atrial fibrillationAtrial fibrillation (AF)Time in therapeutic range (TTR)International normalized ratio (INR)Vitamin K antagonist (VKA)Oral anticoagulants (OACs)Non-vitamin K antagonist oral anticoagulants (Nvitamin K antagonist oral anticoagulants (
- Registration Number
- TCTR20201224003
- Lead Sponsor
- Faculty of Medicine, Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
1. Adult patients (age ≥18 years)
2. Followed up at warfarin clinic in KCMH
3. Diagnosed with non-valvular atrial fibrillation (confirmed by 12-lead ECG or ECG strip with ≥30 seconds of AF, including wearable-recorded ECGs)
4. Using warfarin for at least 2 years
5. Have at least 3 INR per year readings previously for TTR calculation
Exclusion Criteria
1. Rheumatic mitral valve disease
2. Prosthetic valve or valve repair
3. Atrial fibrillation related to transient reversible cause (e.g., during respiratory tract infection)
4. Participation in any other clinical trial
5. Pregnancy
6. History of use DOACs within 2 years
7. Not available to attend follow-up
8. Refusal to participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of TTR change after protocol implementation 1 year Unpaired t test
- Secondary Outcome Measures
Name Time Method Protocol feasibility 1 year Questionnaire,Incidence of bleeding and thromboembolic event 1 year Percent