NCT02810509CompletedNot Applicable
Quality of Anticoagulation With Warfarin in Patient With Atrial Fibrillation for Secondary Stroke Prevention in Korea
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Inje University
- Enrollment
- 1,814
- Locations
- 18
- Primary Endpoint
- Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0.
Study Overview
Brief Summary
The current study aims to assess the quality of anticoagulation with warfarin in real world practice of secondary stroke prevention in Korean patients with Atrial fibrillation (AF) and to explore predictors for poor International Normalized Range (INR) control.
Detailed Description
- To assess the quality of anticoagulation with warfarin in real world practice of Korea for secondary stroke prevention in patients with AF-related Cardioembolic (CE) stroke 1) who initiated warfarin therapy and treatment at least for more than 7 days of warfarin adjustment period (warfarin-initiated cohort), and 2) who initiated and maintained warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period (long-term warfarin-treated cohort).
- To explore predictors for poor INR control.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion criteria for the warfarin-initiated cohort
- •Admission due to AF-related ischemic stroke
- •Initiation of warfarin therapy and treatment at least for more than 7 days of warfarin adjustment period
- •For TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment
- •Inclusion criteria for the long-term warfarin-treated cohort
- •Admission due to AF-related ischemic stroke
- •Long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period
- •For TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment
- •TTR evaluable days ≥ 90 days
Exclusion Criteria
- •AF with mechanical valve
- •Enrollment in anticoagulation randomized clinical trial
- •Enrollment in studies affecting the target INR range.
Outcomes
Primary Outcomes
Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0.
Time Frame: We will analyze INR data of patients who had AF-related ischemic stroke and were treated with warfarin therapy at least for more than 7 days of warfarin adjustment period. (The INR follow up duration: 1 ~ maximum 3 years)
The primary outcome is TTR as measured by the percentage of time in the therapeutic range of INR between 2.0-3.0, using the Rosendaal linear interpolation method.
Secondary Outcomes
- Percentage of INR Values in the Therapeutic Range of 2.0-3.0: Numbers of INR Values Within the Therapeutic Range by the Total Numbers of INR Measured.(We will analyze INR data of patients who had AF-related ischemic stroke and were treated with warfarin therapy at least for more than 7 days of warfarin adjustment period. (The INR follow up duration: 1 ~ maximum 3 years))
Investigators
Keun-Sik Hong
Professor
Inje University
Study Sites (18)
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