Atrial Fibrillation
Conditions
Brief summary
This is an observational study in patients with non-valvular atrial fibrillation (NVAF) presenting to the hospital with a first acute ischemic stroke based on existing data recorded in the SITS International Registry (located in Sweden) by physicians in several European countries, such as Italy, United Kingdom, Czech Republic, Sweden, Germany, Poland, Spain, Finland, Portugal, Slovakia, Denmark, Estonia, Norway Belgium, Hungary, Slovenia, Croatia, Austria, Lithuania, France, Greece, Netherlands, Ireland, Ukraine and Iceland. The aim of this study is to explore the current real world use of dabigatran for stroke prevention in NVAF patients in the post-stroke setting. Secondary data from eligible European patients registered in the SITS registry will be considered; countries of origin are not known a priori.
Interventions
Oral anticoagulant (NOAC) thrombin inhibitor
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with non-valvular Atrial Fibrillation (NVAF) * Patients presenting with their first acute ischemic stroke * ≥18 years of age
Exclusion criteria
\- Documentation that the patient was enrolled or is planned to be enrolled in an investigational clinical trial at the time of the onset of the index event and for the duration of the data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event) | Up to 3 months of follow-up after index event | To evaluate the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation (NVAF) after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | At first ever ischaemic stroke (index event) date, up to 1 day. | The National Institute of Health Stroke Scale (NIHSS) score on patients with non-valvular atrial fibrillation and dabigatran initiation timing information. The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke. Results were reported according to their dabigatran initiation timing categories. |
| Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | At first ever ischaemic stroke (index event) date, up to 1 day. | Previous Modified Rankin Scale (mRS) collected at first ever ischaemic stroke (index event). The Modified Rankin scale (mRS) is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome. Results were reported according to their dabigatran initiation timing categories. |
| Age of Patients According to Dabigatran Initiation Time Period | At first ever ischaemic stroke (index event), up to 1 day. | Age of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. CHA2DS2-VASc and HAS-BLED were used in the statistical analysis. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/transient ischemic attack(TIA), Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalised ratio (INR), Elderly (\>65 years), Drugs and Alcohol Score. |
| Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period | At first ever ischaemic stroke (index event), up to 1 day. | Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. |
| CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period | At first ever ischaemic stroke (index event), up to 1 day. | The Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score of patients according to their start dabigatran time period. CHA2DS2-VASc is used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score ranges from 0 to 9 with 0 being the best outcome. Results were reported according to their dabigatran initiation timing categories. |
| HAS-BLED of Patients According to Dabigatran Initiation Time Period | At first ever ischaemic stroke (index event), up to 1 day. | The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol (HAS-BLED) Score of patients according to their start dabigatran time period. HAS-BLED score ranges from 0 to 9 with higher scores indicating greater risk of bleeding. Results were reported according to their dabigatran initiation timing categories. |
| Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period | At first ever ischaemic stroke (index event), up to 1 day. | Percentage of patients with History of or predisposition to bleeding according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. |
| Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Up to 3 months of follow-up after index event. | Number of time the corresponding reason to delay oral anticoagulation (OAC) entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients. |
| Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | At first ever ischaemic stroke (index event), up to 1 day. | Physicians' reason to delay dabigatran initiation according to their start dabigatran time period. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients. |
| Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Up to 3 months of follow-up after index event. | Number of times of corresponding reason of choosing daily dosage of 220 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients. |
| Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Up to 3 months of follow-up after index event. | Number of times the corresponding reason for choosing daily dosage of 300 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients. |
Countries
Sweden
Participant flow
Recruitment details
This retrospective study using existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry assessed the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation after the first ever ischemic stroke (3 months of follow-up thereafter) to prevent secondary stroke.
Pre-assignment details
In this non-interventional study based on existing data, no patients were screened.
Baseline characteristics
| Characteristic | Total | — |
|---|---|---|
| Age, Continuous | 75 Years STANDARD_DEVIATION 10 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 788 Participants | — |
| Sex: Female, Male Male | 701 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event)
To evaluate the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation (NVAF) after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke.
Time frame: Up to 3 months of follow-up after index event
Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total | Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event) | > 7 - 14 d | 33.1 Percentage of participants |
| Total | Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event) | 0 - 24 hours (h) | 5.9 Percentage of participants |
| Total | Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event) | > 24 - 72 h | 15.3 Percentage of participants |
| Total | Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event) | > 3 - 7 days (d) | 27.7 Percentage of participants |
| Total | Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event) | > 14 - 28 d | 14.0 Percentage of participants |
| Total | Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event) | > 28 d - 3 months | 4.0 Percentage of participants |
Age of Patients According to Dabigatran Initiation Time Period
Age of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. CHA2DS2-VASc and HAS-BLED were used in the statistical analysis. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/transient ischemic attack(TIA), Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalised ratio (INR), Elderly (\>65 years), Drugs and Alcohol Score.
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | Age of Patients According to Dabigatran Initiation Time Period | 72 Years | Standard Deviation 11 |
| > 24 - 72 Hours | Age of Patients According to Dabigatran Initiation Time Period | 74 Years | Standard Deviation 10 |
| > 3 - 7 Days | Age of Patients According to Dabigatran Initiation Time Period | 75 Years | Standard Deviation 9 |
| > 7 - 14 Days | Age of Patients According to Dabigatran Initiation Time Period | 75 Years | Standard Deviation 9 |
| > 14 - 28 Days | Age of Patients According to Dabigatran Initiation Time Period | 76 Years | Standard Deviation 9 |
| > 28 Days - 3 Months | Age of Patients According to Dabigatran Initiation Time Period | 77 Years | Standard Deviation 10 |
CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period
The Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score of patients according to their start dabigatran time period. CHA2DS2-VASc is used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score ranges from 0 to 9 with 0 being the best outcome. Results were reported according to their dabigatran initiation timing categories.
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total | CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period | 5 Score on a scale |
| > 24 - 72 Hours | CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period | 5 Score on a scale |
| > 3 - 7 Days | CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period | 5 Score on a scale |
| > 7 - 14 Days | CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period | 5 Score on a scale |
| > 14 - 28 Days | CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period | 5 Score on a scale |
| > 28 Days - 3 Months | CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period | 5 Score on a scale |
Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period
Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period | 87 millimetre of mercury (mm Hg) | Standard Deviation 12 |
| > 24 - 72 Hours | Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period | 83 millimetre of mercury (mm Hg) | Standard Deviation 15 |
| > 3 - 7 Days | Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period | 84 millimetre of mercury (mm Hg) | Standard Deviation 14 |
| > 7 - 14 Days | Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period | 85 millimetre of mercury (mm Hg) | Standard Deviation 15 |
| > 14 - 28 Days | Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period | 85 millimetre of mercury (mm Hg) | Standard Deviation 17 |
| > 28 Days - 3 Months | Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period | 91 millimetre of mercury (mm Hg) | Standard Deviation 16 |
HAS-BLED of Patients According to Dabigatran Initiation Time Period
The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol (HAS-BLED) Score of patients according to their start dabigatran time period. HAS-BLED score ranges from 0 to 9 with higher scores indicating greater risk of bleeding. Results were reported according to their dabigatran initiation timing categories.
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total | HAS-BLED of Patients According to Dabigatran Initiation Time Period | 3 Score on a scale |
| > 24 - 72 Hours | HAS-BLED of Patients According to Dabigatran Initiation Time Period | 3 Score on a scale |
| > 3 - 7 Days | HAS-BLED of Patients According to Dabigatran Initiation Time Period | 3 Score on a scale |
| > 7 - 14 Days | HAS-BLED of Patients According to Dabigatran Initiation Time Period | 3 Score on a scale |
| > 14 - 28 Days | HAS-BLED of Patients According to Dabigatran Initiation Time Period | 3 Score on a scale |
| > 28 Days - 3 Months | HAS-BLED of Patients According to Dabigatran Initiation Time Period | 3 Score on a scale |
National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
The National Institute of Health Stroke Scale (NIHSS) score on patients with non-valvular atrial fibrillation and dabigatran initiation timing information. The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke. Results were reported according to their dabigatran initiation timing categories.
Time frame: At first ever ischaemic stroke (index event) date, up to 1 day.
Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total | National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | 8 Score on a scale |
| > 24 - 72 Hours | National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | 8 Score on a scale |
| > 3 - 7 Days | National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | 8 Score on a scale |
| > 7 - 14 Days | National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | 12 Score on a scale |
| > 14 - 28 Days | National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | 14 Score on a scale |
| > 28 Days - 3 Months | National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | 15 Score on a scale |
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Number of times of corresponding reason of choosing daily dosage of 220 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Time frame: Up to 3 months of follow-up after index event.
Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Haemorrhagic transformation | 6 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Intracranial Haemorrhage (ICH) spontaneous | 3 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Severity of stroke | 18 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Size of infarct | 13 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Location of infarct | 8 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Intervention used to treat stroke | 4 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Altered coagulation parameters | 7 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Patients bleeding risk | 6.3 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Patients stroke risk | 27 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Recommendation from specialist | 32 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Reason is not specified | 95 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Other reasons | 10 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Patients age | 209 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Co-medication | 11 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Co-morbidities | 16 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians | Renal function | 48 Times |
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Number of times the corresponding reason for choosing daily dosage of 300 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Time frame: Up to 3 months of follow-up after index event.
Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Intracranial Haemorrhage (ICH) spontaneous | 1 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Severity of stroke | 38 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Size of infarct | 16 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Location of infarct | 18 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Intervention used to treat stroke | 3 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Altered coagulation parameters | 10 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Patients bleeding risk | 34 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Patients stroke risk | 89 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Recommendation from specialist | 50 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Reason is not specified | 216 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Other reasons | 1 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Patients age | 139 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Co-medication | 5 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Co-morbidities | 19 Times |
| Total | Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians | Renal function | 47 Times |
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Physicians' reason to delay dabigatran initiation according to their start dabigatran time period. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Haemorrhagic transformation | 0 Times |
| Total | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Intracranial Haemorrhage (ICH) pontaneous | 0 Times |
| Total | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Severity Infarct | 0 Times |
| Total | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Size of Infarct | 0 Times |
| Total | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Location Infarct | 0 Times |
| Total | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Intervention used to treat ischemic stroke | 0 Times |
| Total | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Altered coagulation parameters | 0 Times |
| Total | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Patients bleeding risk factors | 0 Times |
| Total | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Patients stroke risk factors | 0 Times |
| Total | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Recommendation from specialist | 0 Times |
| Total | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Practical considerations | 1 Times |
| Total | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Reason is not specified | 0 Times |
| Total | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Other reasons | 0 Times |
| > 24 - 72 Hours | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Severity Infarct | 0 Times |
| > 24 - 72 Hours | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Other reasons | 0 Times |
| > 24 - 72 Hours | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Haemorrhagic transformation | 0 Times |
| > 24 - 72 Hours | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Patients bleeding risk factors | 1 Times |
| > 24 - 72 Hours | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Practical considerations | 1 Times |
| > 24 - 72 Hours | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Intervention used to treat ischemic stroke | 0 Times |
| > 24 - 72 Hours | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Intracranial Haemorrhage (ICH) pontaneous | 0 Times |
| > 24 - 72 Hours | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Patients stroke risk factors | 0 Times |
| > 24 - 72 Hours | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Reason is not specified | 0 Times |
| > 24 - 72 Hours | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Recommendation from specialist | 0 Times |
| > 24 - 72 Hours | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Location Infarct | 0 Times |
| > 24 - 72 Hours | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Altered coagulation parameters | 0 Times |
| > 24 - 72 Hours | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Size of Infarct | 0 Times |
| > 3 - 7 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Altered coagulation parameters | 0 Times |
| > 3 - 7 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Patients stroke risk factors | 0 Times |
| > 3 - 7 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Patients bleeding risk factors | 0 Times |
| > 3 - 7 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Size of Infarct | 2 Times |
| > 3 - 7 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Severity Infarct | 1 Times |
| > 3 - 7 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Haemorrhagic transformation | 2 Times |
| > 3 - 7 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Location Infarct | 0 Times |
| > 3 - 7 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Intracranial Haemorrhage (ICH) pontaneous | 0 Times |
| > 3 - 7 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Practical considerations | 0 Times |
| > 3 - 7 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Intervention used to treat ischemic stroke | 0 Times |
| > 3 - 7 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Reason is not specified | 1 Times |
| > 3 - 7 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Recommendation from specialist | 0 Times |
| > 3 - 7 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Other reasons | 0 Times |
| > 7 - 14 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Patients bleeding risk factors | 4 Times |
| > 7 - 14 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Severity Infarct | 7 Times |
| > 7 - 14 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Size of Infarct | 9 Times |
| > 7 - 14 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Reason is not specified | 5 Times |
| > 7 - 14 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Location Infarct | 3 Times |
| > 7 - 14 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Intervention used to treat ischemic stroke | 2 Times |
| > 7 - 14 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Altered coagulation parameters | 2 Times |
| > 7 - 14 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Patients stroke risk factors | 2 Times |
| > 7 - 14 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Recommendation from specialist | 0 Times |
| > 7 - 14 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Other reasons | 0 Times |
| > 7 - 14 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Practical considerations | 0 Times |
| > 7 - 14 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Haemorrhagic transformation | 2 Times |
| > 7 - 14 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Intracranial Haemorrhage (ICH) pontaneous | 1 Times |
| > 14 - 28 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Patients stroke risk factors | 2 Times |
| > 14 - 28 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Intervention used to treat ischemic stroke | 3 Times |
| > 14 - 28 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Recommendation from specialist | 2 Times |
| > 14 - 28 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Severity Infarct | 12 Times |
| > 14 - 28 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Reason is not specified | 4 Times |
| > 14 - 28 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Intracranial Haemorrhage (ICH) pontaneous | 3 Times |
| > 14 - 28 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Practical considerations | 3 Times |
| > 14 - 28 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Location Infarct | 2 Times |
| > 14 - 28 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Haemorrhagic transformation | 8 Times |
| > 14 - 28 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Other reasons | 1 Times |
| > 14 - 28 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Patients bleeding risk factors | 6 Times |
| > 14 - 28 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Altered coagulation parameters | 1 Times |
| > 14 - 28 Days | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Size of Infarct | 12 Times |
| > 28 Days - 3 Months | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Practical considerations | 3 Times |
| > 28 Days - 3 Months | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Patients stroke risk factors | 1 Times |
| > 28 Days - 3 Months | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Reason is not specified | 1 Times |
| > 28 Days - 3 Months | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Intervention used to treat ischemic stroke | 0 Times |
| > 28 Days - 3 Months | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Altered coagulation parameters | 0 Times |
| > 28 Days - 3 Months | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Severity Infarct | 2 Times |
| > 28 Days - 3 Months | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Size of Infarct | 3 Times |
| > 28 Days - 3 Months | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Recommendation from specialist | 1 Times |
| > 28 Days - 3 Months | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Intracranial Haemorrhage (ICH) pontaneous | 0 Times |
| > 28 Days - 3 Months | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Patients bleeding risk factors | 0 Times |
| > 28 Days - 3 Months | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Location Infarct | 0 Times |
| > 28 Days - 3 Months | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Haemorrhagic transformation | 1 Times |
| > 28 Days - 3 Months | Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period | Other reasons | 0 Times |
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Number of time the corresponding reason to delay oral anticoagulation (OAC) entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Time frame: Up to 3 months of follow-up after index event.
Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total | Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Haemorrhagic transformation | 40 Times |
| Total | Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Intracranial Haemorrhage (ICH) Spontaneous | 8 Times |
| Total | Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Severity Infarct | 61 Times |
| Total | Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Size of Infarct | 52 Times |
| Total | Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Location Infarct | 14 Times |
| Total | Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Intervention used to treat ischemic stroke | 8 Times |
| Total | Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Altered coagulation parameters | 5 Times |
| Total | Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Patients bleeding risk factors | 18 Times |
| Total | Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Patients stroke risk factors | 6 Times |
| Total | Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Patient preference | 4 Times |
| Total | Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Recommendation from specialist | 6 Times |
| Total | Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Practical considerations | 14 Times |
| Total | Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Reason is not specified | 27 Times |
| Total | Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. | Other reasons | 5 Times |
Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period
Percentage of patients with History of or predisposition to bleeding according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total | Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period | 2.1 Percentage of participants |
| > 24 - 72 Hours | Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period | 1.1 Percentage of participants |
| > 3 - 7 Days | Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period | 3.0 Percentage of participants |
| > 7 - 14 Days | Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period | 3.0 Percentage of participants |
| > 14 - 28 Days | Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period | 1.8 Percentage of participants |
| > 28 Days - 3 Months | Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period | 4.4 Percentage of participants |
Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
Previous Modified Rankin Scale (mRS) collected at first ever ischaemic stroke (index event). The Modified Rankin scale (mRS) is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome. Results were reported according to their dabigatran initiation timing categories.
Time frame: At first ever ischaemic stroke (index event) date, up to 1 day.
Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total | Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | 0 Score on a scale |
| > 24 - 72 Hours | Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | 0 Score on a scale |
| > 3 - 7 Days | Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | 0 Score on a scale |
| > 7 - 14 Days | Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | 0 Score on a scale |
| > 14 - 28 Days | Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | 0 Score on a scale |
| > 28 Days - 3 Months | Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | 0 Score on a scale |