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

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ClinicalTrials.gov Identifier: NCT02810509
Recruitment Status : Completed
First Posted : June 23, 2016
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Keun-Sik Hong, Inje University

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Conditions Atrial Fibrillation
Stroke
Enrollment 1814
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Short Term Wafarin-treated Cohort Long Term Warfarin-treated Cohort
Hide Arm/Group Description
  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
  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
Period Title: Overall Study
Started 584 1230
Completed 584 1230
Not Completed 0 0
Arm/Group Title Short Term Wafarin-treated Cohort Long Term Warfarin-treated Cohort Total
Hide Arm/Group Description
  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
  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 Time in TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment
  4. TTR evaluable days ≥ 90 days
Total of all reporting groups
Overall Number of Baseline Participants 584 1230 1814
Hide Baseline Analysis Population Description
Overall number of Baseline participants are divided by short term and Long term Warfarin-treated cohort.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 584 participants 1230 participants 1814 participants
73.71  (9.60) 70.08  (9.73) 71.25  (9.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 584 participants 1230 participants 1814 participants
Female 298 523 821
Male 286 707 993
1.Primary Outcome
Title Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Short-term Cohort Long-term Cohort
Hide Arm/Group Description:
  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
  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
Overall Number of Participants Analyzed 584 1230
Mean (Standard Deviation)
Unit of Measure: 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.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Short-term Cohort Long-term Cohort
Hide Arm/Group Description:
  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
  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 Time in TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment
  4. TTR evaluable days ≥ 90 days
Overall Number of Participants Analyzed 584 1230
Overall Number of Units Analyzed
Type of Units Analyzed: Number of INR measured
8693 33941
Count of Units
Unit of Measure: Number of INR measured
3900
  44.9%
15120
  44.5%
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
Hide Arm/Group Description
  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 Time in therapeutic range (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 Time in TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment
  4. TTR evaluable days ≥ 90 days
All-Cause Mortality
Warfarin-initiated Cohort Long Term Warfarin-treated Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Warfarin-initiated Cohort Long Term Warfarin-treated Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Warfarin-initiated Cohort Long Term Warfarin-treated Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Keun-Sik Hong, MD, PhD, Prof
Organization: Ilsan Paik Hospital Inje University
Phone: 82-31-910-7680
EMail: nrhks@paik.ac.kr
Layout table for additonal information
Responsible Party: Keun-Sik Hong, Inje University
ClinicalTrials.gov Identifier: NCT02810509     History of Changes
Other Study ID Numbers: Warfarin TTR-01
First Submitted: December 23, 2015
First Posted: June 23, 2016
Results First Submitted: January 25, 2017
Results First Posted: September 13, 2019
Last Update Posted: September 13, 2019