Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-term Warfarin-treated cohort |
| ||
| Long-term Warfarin-treated cohort |
|
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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) |
Not provided
Inclusion Criteria:
Inclusion criteria for the warfarin-initiated cohort
Inclusion criteria for the long-term warfarin-treated cohort
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Keun-Sik Hong, MD, Phd | Department of Neurology, Ilsan Paik Hospital Inje University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University College of Medicine | Anyang | South Korea | ||||
| Dong-A University College of Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Short Term Wafarin-treated Cohort |
|
| FG001 | Long Term Warfarin-treated Cohort |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Busan |
| South Korea |
| Yeungnam University School of Medicine | Daegu | South Korea |
| Dongguk University Ilsan Hospital | Goyang | South Korea |
| Chonnam National University Medical School | Gwangju | South Korea |
| Ilsan Paik Hospital Inje University | Ilsan | South Korea |
| Inha University Hospital | Incheon | South Korea |
| Jeju National University Hospital, Jeju National University College of Medicine | Jeju City | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Eulji General Hospital, Eulji University School of Medicine | Seoul | South Korea |
| Korea University College of Medicine | Seoul | South Korea |
| Samsung Medical Center, Sungkyunkwan University School of Medicine | Seoul | South Korea |
| Seoul Medical Center | Seoul | South Korea |
| Seoul National University College of Medicine | Seoul | South Korea |
| Soonchunhyang University College of Medicine | Seoul | South Korea |
| Soonchunhyang University | Seoul | South Korea |
| University of Ulsan College of Medicine | Seoul | South Korea |
| Yonsei University College of Medicine | Seoul | South Korea |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Overall number of Baseline participants are divided by short term and Long term Warfarin-treated cohort.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Short Term Wafarin-treated Cohort |
|
| BG001 | Long Term Warfarin-treated Cohort |
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of time in therapeutic range | 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 | 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. | 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. | Posted | Count of Units | Number 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) | Number of INR measured | Number of INR measured |
|
|
This is an investigator-initiated study of a retrospective observation study therefore, adverse events and serious adverse events are not collected through this study.
This is an investigator-initiated study of a retrospective observation study therefore, adverse events and serious adverse events are not collected through this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Warfarin-initiated Cohort |
| 0 | 0 | 0 | 0 | ||
| EG001 | Long Term Warfarin-treated Cohort |
| 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keun-Sik Hong, MD, PhD, Prof | Ilsan Paik Hospital Inje University | 82-31-910-7680 | nrhks@paik.ac.kr |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| Male |
|
| Counts |
|---|
| Participants |
|
| Number of INR measured |
|
|