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

• Sponsor: Inje University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02810509
• Collaborator: (none)
• Enrollment: 1,814
• Locations: 18
• Duration (Months): 16
• Patients Per Site: 100.8
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Stroke

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
• Actual Enrollment: 1814 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Quality of Anticoagulation With Warfarin in Patient With Atrial Fibrillation for Secondary Stroke Prevention in Korea
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Short-term Warfarin-treated cohort admission due to AF-related ischemic stroke (known AF or newly detected AF) for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment TTR evaluable days < 90 days
Long-term Warfarin-treated cohort admission due to AF-related ischemic stroke (known AF or newly detected AF) long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment TTR evaluable days ≥ 90 days

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hallym University College of Medicine	Anyang		Korea, Republic of
2	Dong-A University College of Medicine	Busan		Korea, Republic of
3	Yeungnam University School of Medicine	Daegu		Korea, Republic of
4	Dongguk University Ilsan Hospital	Goyang		Korea, Republic of
5	Chonnam National University Medical School	Gwangju		Korea, Republic of
6	Ilsan Paik Hospital Inje University	Ilsan		Korea, Republic of
7	Inha University Hospital	Incheon		Korea, Republic of
8	Jeju National University Hospital, Jeju National University College of Medicine	Jeju		Korea, Republic of
9	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of
10	Eulji General Hospital, Eulji University School of Medicine	Seoul		Korea, Republic of
11	Korea University College of Medicine	Seoul		Korea, Republic of
12	Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul		Korea, Republic of
13	Seoul Medical Center	Seoul		Korea, Republic of
14	Seoul National University College of Medicine	Seoul		Korea, Republic of
15	Soonchunhyang University College of Medicine	Seoul		Korea, Republic of
16	Soonchunhyang University	Seoul		Korea, Republic of
17	University of Ulsan College of Medicine	Seoul		Korea, Republic of
18	Yonsei University College of Medicine	Seoul		Korea, Republic of

Sponsors and Collaborators

• Inje University

Investigators

• Principal Investigator: Keun-Sik Hong, MD, Phd, Department of Neurology, Ilsan Paik Hospital Inje University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Keun-Sik Hong, Professor, Inje University
• ClinicalTrials.gov Identifier: NCT02810509
• Other Study ID Numbers: Warfarin TTR-01
• First Posted: Jun 23, 2016
• Last Update Posted: Sep 13, 2019
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Keun-Sik Hong, Professor, Inje University: Wafarin; Cardioembolic (CE) stroke; ischemic stroke
• Additional relevant MeSH terms: Stroke; Atrial Fibrillation

Study Results

Participant Flow

Arm/Group Title	Short Term Wafarin-treated Cohort	Long Term Warfarin-treated Cohort
Arm/Group Description	admission due to AF-related ischemic stroke (known AF or newly detected AF) for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment TTR evaluable days < 90 days	admission due to AF-related ischemic stroke (known AF or newly detected AF) long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment TTR evaluable days ≥ 90 days
Period Title: Overall Study
STARTED	584	1230
COMPLETED	584	1230
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Short Term Wafarin-treated Cohort	Long Term Warfarin-treated Cohort	Total
Arm/Group Description	Admission due to AF-related ischemic stroke (known AF or newly detected AF) for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment TTR evaluable days < 90 days	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 Time in TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment TTR evaluable days ≥ 90 days	Total of all reporting groups
Overall Participants	584	1230	1814
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.71 (9.60)	70.08 (9.73)	71.25 (9.83)
Sex: Female, Male (Count of Participants)
Female	298 51%	523 42.5%	821 45.3%
Male	286 49%	707 57.5%	993 54.7%

Outcome Measures

1. Primary Outcome

Title	Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0.
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Short-term Cohort	Long-term Cohort
Arm/Group Description	admission due to AF-related ischemic stroke (known AF or newly detected AF) for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment TTR evaluable days < 90 days	admission due to AF-related ischemic stroke (known AF or newly detected AF) long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment TTR evaluable days ≥ 90 days
Measure Participants	584	1230
Mean (Standard Deviation) [percentage of time in therapeutic range]	43.4 (26.3)	49.1 (20.8)

2. Secondary Outcome

Title	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.
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Short-term Cohort	Long-term Cohort
Arm/Group Description	Admission due to AF-related ischemic stroke (known AF or newly detected AF) for TTR calculation, the number of consecutive INR measurements ≥3 after the 7 days of warfarin adjustment TTR evaluable days < 90 days	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 Time in TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment TTR evaluable days ≥ 90 days
Measure Participants	584	1230
Measure Number of INR measured	8693	33941
Count of Units [Number of INR measured]	3900	15120

Adverse Events

Time Frame	This is an investigator-initiated study of a retrospective observation study therefore, adverse events and serious adverse events are not collected through this study.
Adverse Event Reporting Description	This is an investigator-initiated study of a retrospective observation study therefore, adverse events and serious adverse events are not collected through this study.
Arm/Group Title	Warfarin-initiated Cohort		Long Term Warfarin-treated Cohort
Arm/Group Description	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 Time in therapeutic range (TTR) calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment		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 Time in TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment TTR evaluable days ≥ 90 days
All Cause Mortality
	Warfarin-initiated Cohort		Long Term Warfarin-treated Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Warfarin-initiated Cohort		Long Term Warfarin-treated Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Warfarin-initiated Cohort		Long Term Warfarin-treated Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.