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Completed

NCT Number: NCT02810509

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hallym University College of Medicine, Anyang, South Korea

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for the warfarin-initiated cohort

  • 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

Inclusion criteria

for the long-term warfarin-treated cohort

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0.

    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)

    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 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.

    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)

    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.

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 23, 2016
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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