Trial Outcomes & Findings for Quality of Anticoagulation With Warfarin in Patient With Atrial Fibrillation for Secondary Stroke Prevention in Korea (NCT NCT02810509)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1814 participants

Primary outcome timeframe

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)

Results posted on

2019-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	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	Long Term Warfarin-treated Cohort 1. admission due to AF-related ischemic stroke (known AF or newly detected AF) 2. long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period 3. for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment 4. TTR evaluable days ≥ 90 days
Overall Study STARTED	584	1230
Overall Study COMPLETED	584	1230
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quality of Anticoagulation With Warfarin in Patient With Atrial Fibrillation for Secondary Stroke Prevention in Korea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Short Term Wafarin-treated Cohort n=584 Participants 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	Long Term Warfarin-treated Cohort n=1230 Participants 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	Total n=1814 Participants Total of all reporting groups
Age, Continuous	73.71 years STANDARD_DEVIATION 9.60 • n=5 Participants	70.08 years STANDARD_DEVIATION 9.73 • n=7 Participants	71.25 years STANDARD_DEVIATION 9.83 • n=5 Participants
Sex: Female, Male Female	298 Participants n=5 Participants	523 Participants n=7 Participants	821 Participants n=5 Participants
Sex: Female, Male Male	286 Participants n=5 Participants	707 Participants n=7 Participants	993 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Short-term Cohort n=584 Participants 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	Long-term Cohort n=1230 Participants 1. admission due to AF-related ischemic stroke (known AF or newly detected AF) 2. long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period 3. for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment 4. TTR evaluable days ≥ 90 days
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	49.1 percentage of time in therapeutic range Standard Deviation 20.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Short-term Cohort n=8693 Number of INR measured 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	Long-term Cohort n=33941 Number of INR measured 1. admission due to AF-related ischemic stroke (known AF or newly detected AF) 2. long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period 3. for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment 4. TTR evaluable days ≥ 90 days
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	15120 Number of INR measured

Adverse Events

Warfarin-initiated Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Long Term Warfarin-treated Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Keun-Sik Hong, MD, PhD, Prof

Ilsan Paik Hospital Inje University

Phone: 82-31-910-7680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place