Clinical trial NCT02810509: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Stroke
Keywords: Wafarin
Cardioembolic (CE) stroke
ischemic stroke
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 1814
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0.
timeFrame: 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:
measure: 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.
timeFrame: 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)
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University College of Medicine
city: Busan
country: Korea, Republic of
facility: Dong-A University College of Medicine
city: Daegu
country: Korea, Republic of
facility: Yeungnam University School of Medicine
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Medical School
city: Ilsan
country: Korea, Republic of
facility: Ilsan Paik Hospital Inje University
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital, Jeju National University College of Medicine
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital, Eulji University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Korea University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University
city: Seoul
country: Korea, Republic of
facility: University of Ulsan College of Medicine
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
affiliation: Department of Neurology, Ilsan Paik Hospital Inje University
name: Keun-Sik Hong, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: