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

NCT02810509 | Completed Results DMC

• 1 other identifier: Warfarin TTR-01
• Study Type: observational
• Target: 1,814
• Locations: 1 country
• Sites: 18

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.

Conditions

Atrial Fibrillation; Stroke

Keywords

Wafarin; Cardioembolic (CE) stroke; ischemic stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

Secondary Outcomes (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)

Study Arms (2)

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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients who admitted to 16 participating centers due to AF-related ischemic stroke between Jan 1, 2011 and Dec 31, 2012 and started warfarin therapy for secondary stroke prevention will be enrolled in this study. The number of patients is expected to be 2,217 for the warfarin-initiated cohort and 1,057 for the long-term warfarin-treated cohort.

You may qualify if:

• 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 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 TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment
• TTR evaluable days ≥ 90 days

You may not qualify if:

• AF with mechanical valve
• Enrollment in anticoagulation randomized clinical trial
• Enrollment in studies affecting the target INR range.

Sponsors & Collaborators

• Inje University: lead

Study Sites (18)

Hallym University College of Medicine

Anyang, South Korea

Location

Dong-A University College of Medicine

Busan, South Korea

Location

Yeungnam University School of Medicine

Daegu, South Korea

Location

Dongguk University Ilsan Hospital

Goyang, South Korea

Location

Chonnam National University Medical School

Gwangju, South Korea

Location

Ilsan Paik Hospital Inje University

Ilsan, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Jeju National University Hospital, Jeju National University College of Medicine

Jeju City, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Eulji General Hospital, Eulji University School of Medicine

Seoul, South Korea

Location

Korea University College of Medicine

Seoul, South Korea

Location

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, South Korea

Location

Seoul Medical Center

Seoul, South Korea

Location

Seoul National University College of Medicine

Seoul, South Korea

Location

Soonchunhyang University College of Medicine

Seoul, South Korea

Location

Soonchunhyang University

Seoul, South Korea

Location

University of Ulsan College of Medicine

Seoul, South Korea

Location

Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Results Point of Contact

• Title: Keun-Sik Hong, MD, PhD, Prof
• Organization: Ilsan Paik Hospital Inje University

nrhks@paik.ac.kr

82-31-910-7680

Study Officials

• Keun-Sik Hong, MD, Phd

  Department of Neurology, Ilsan Paik Hospital Inje University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: June 23, 2016
• Study Start: June 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 13, 2019
• Results First Posted: September 13, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (18)