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Trial record 47 of 231 for:    warfarin AND International

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

Tracking Information
First Submitted Date December 23, 2015
First Posted Date June 23, 2016
Results First Submitted Date January 25, 2017
Results First Posted Date September 13, 2019
Last Update Posted Date September 13, 2019
Study Start Date June 2015
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 8, 2019)
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.
Original Primary Outcome Measures
 (submitted: June 20, 2016)
Time in TTR, the proportion 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 proportion of time in the therapeutic range of INR between 2.0-3.0, using the Rosendaal linear interpolation method.
Change History Complete list of historical versions of study NCT02810509 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 8, 2019)
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.
Original Secondary Outcome Measures
 (submitted: June 20, 2016)
Proportion of INR in the therapeutic range of 2.0-3.0: numbers of INR 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 proportion of INR in the therapeutic range of 2.0-3.0: numbers of INR measures within the therapeutic range divided by the total numbers of INR measured.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality of Anticoagulation With Warfarin in Patient With Atrial Fibrillation for Secondary Stroke Prevention in Korea
Official Title Quality of Anticoagulation With Warfarin in Patient With Atrial Fibrillation for Secondary Stroke Prevention in Korea
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Atrial Fibrillation
  • Stroke
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 8, 2019)
1814
Original Estimated Enrollment
 (submitted: June 20, 2016)
2217
Actual Study Completion Date October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02810509
Other Study ID Numbers Warfarin TTR-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Keun-Sik Hong, Inje University
Study Sponsor Inje University
Collaborators Not Provided
Investigators
Principal Investigator: Keun-Sik Hong, MD, Phd Department of Neurology, Ilsan Paik Hospital Inje University
PRS Account Inje University
Verification Date August 2018