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

NCT ID: NCT02810509

Last Updated: 2019-09-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1814 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-10-31

Brief Summary

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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

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* 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.

Conditions

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Atrial Fibrillation Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Short-term Warfarin-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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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


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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Keun-Sik Hong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keun-Sik Hong, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Ilsan Paik Hospital Inje University

Locations

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Hallym University College of Medicine

Anyang, , South Korea

Site Status

Dong-A University College of Medicine

Busan, , South Korea

Site Status

Yeungnam University School of Medicine

Daegu, , South Korea

Site Status

Dongguk University Ilsan Hospital

Goyang, , South Korea

Site Status

Chonnam National University Medical School

Gwangju, , South Korea

Site Status

Ilsan Paik Hospital Inje University

Ilsan, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

Jeju National University Hospital, Jeju National University College of Medicine

Jeju City, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Eulji General Hospital, Eulji University School of Medicine

Seoul, , South Korea

Site Status

Korea University College of Medicine

Seoul, , South Korea

Site Status

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, , South Korea

Site Status

Seoul Medical Center

Seoul, , South Korea

Site Status

Seoul National University College of Medicine

Seoul, , South Korea

Site Status

Soonchunhyang University College of Medicine

Seoul, , South Korea

Site Status

Soonchunhyang University

Seoul, , South Korea

Site Status

University of Ulsan College of Medicine

Seoul, , South Korea

Site Status

Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Warfarin TTR-01

Identifier Type: -

Identifier Source: org_study_id

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