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

Completed

• Conditions: Atrial Fibrillation; Stroke

• Registration Number: NCT02810509
• Lead Sponsor: Inje University

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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-23
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2017-01-25
• Status Verified: 2018-08
• Results First Submitted QC: 2019-08-08
• Last Update Submitted: 2019-08-08
• Results First Posted: 2019-09-13
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1814

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (18)

Dongguk University Ilsan Hospital; 🇰🇷 Goyang, Korea, Republic of

Hallym University College of Medicine; 🇰🇷 Anyang, Korea, Republic of

Korea University College of Medicine; 🇰🇷 Seoul, Korea, Republic of

Yeungnam University School of Medicine; 🇰🇷 Daegu, Korea, Republic of

Dong-A University College of Medicine; 🇰🇷 Busan, Korea, Republic of

Chonnam National University Medical School; 🇰🇷 Gwangju, Korea, Republic of

Ilsan Paik Hospital Inje University; 🇰🇷 Ilsan, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Jeju National University Hospital, Jeju National University College of Medicine; 🇰🇷 Jeju, Korea, Republic of

Samsung Medical Center, Sungkyunkwan University School of Medicine; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Seoul National University College of Medicine; 🇰🇷 Seoul, Korea, Republic of

Soonchunhyang University College of Medicine; 🇰🇷 Seoul, Korea, Republic of

Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of

University of Ulsan College of Medicine; 🇰🇷 Seoul, Korea, Republic of

Soonchunhyang University; 🇰🇷 Seoul, Korea, Republic of

Eulji General Hospital, Eulji University School of Medicine; 🇰🇷 Seoul, Korea, Republic of

Seoul Medical Center; 🇰🇷 Seoul, Korea, Republic of