Atrial Fibrillation, Stroke
Conditions
Keywords
Wafarin, Cardioembolic (CE) stroke, ischemic stroke
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.
Interventions
None listed
Sponsors
Inje University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for the warfarin-initiated cohort 1. Admission due to AF-related ischemic stroke 2. Initiation of warfarin therapy and treatment at least for more than 7 days of warfarin adjustment period 3. For TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment Inclusion criteria for the long-term warfarin-treated cohort 1. Admission due to AF-related ischemic stroke 2. Long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period 3. For TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment 4. TTR evaluable days ≥ 90 days
Exclusion criteria
1. AF with mechanical valve 2. Enrollment in anticoagulation randomized clinical trial 3. Enrollment in studies affecting the target INR range.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | The secondary outcome is the percentage of INR values in the therapeutic range of 2.0-3.0: numbers of INR values within the therapeutic range divided by the total numbers of INR measured. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Short Term Wafarin-treated Cohort 1. Admission due to AF-related ischemic stroke (known AF or newly detected AF)
2. for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment
3. TTR evaluable days \< 90 days | 584 |
| Long Term Warfarin-treated Cohort 1. Admission due to AF-related ischemic stroke
2. Long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period
3. For Time in TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment
4. TTR evaluable days ≥ 90 days | 1,230 |
| Total | 1,814 |
Baseline characteristics
| Characteristic | Short Term Wafarin-treated Cohort | Long Term Warfarin-treated Cohort | Total |
|---|---|---|---|
| Age, Continuous | 73.71 years STANDARD_DEVIATION 9.6 | 70.08 years STANDARD_DEVIATION 9.73 | 71.25 years STANDARD_DEVIATION 9.83 |
| Sex: Female, Male Female | 298 Participants | 523 Participants | 821 Participants |
| Sex: Female, Male Male | 286 Participants | 707 Participants | 993 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0.
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.
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short-term Cohort | Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0. | 43.4 percentage of time in therapeutic range | Standard Deviation 26.3 |
| Long-term Cohort | Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0. | 49.1 percentage of time in therapeutic range | Standard Deviation 20.8 |
Secondary
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.
The secondary outcome is the percentage of INR values in the therapeutic range of 2.0-3.0: numbers of INR values within the therapeutic range divided by the total numbers of INR measured.
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)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Short-term Cohort | 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. | 3900 Number of INR measured |
| Long-term Cohort | 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. | 15120 Number of INR measured |