Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute ischemic stroke | Non-valvular atrial fibrillation patients hospitalized with an acute ischemic stroke |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran | Drug | Oral anticoagulant (NOAC) thrombin inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 3 months of follow-up after index event |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion criteria:
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
Not provided
Not provided
Not provided
1000
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SITS International (c/o Karolinska University Hospital) | Stockholm | 171 76 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32434935 | Derived | Escudero-Martinez I, Mazya M, Teutsch C, Lesko N, Gdovinova Z, Barbarini L, Fryze W, Karlinski M, Kobayashi A, Krastev G, Paiva Nunes A, Pasztoova K, Peeters A, Sobolewski P, Vilionskis A, Toni D, Ahmed N; SITS Investigators. Dabigatran initiation in patients with non-valvular AF and first acute ischaemic stroke: a retrospective observational study from the SITS registry. BMJ Open. 2020 May 19;10(5):e037234. doi: 10.1136/bmjopen-2020-037234. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this non-interventional study based on existing data, no patients were screened.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Total | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke based on existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 5, 2017 | Jun 9, 2020 |
Not provided
Not provided
Not provided
Not provided
| At first ever ischaemic stroke (index event) date, up to 1 day. |
| 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. | At first ever ischaemic stroke (index event) date, up to 1 day. |
| 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. | At first ever ischaemic stroke (index event), up to 1 day. |
| 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. | At first ever ischaemic stroke (index event), up to 1 day. |
| 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. | At first ever ischaemic stroke (index event), up to 1 day. |
| 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. | At first ever ischaemic stroke (index event), up to 1 day. |
| 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. | At first ever ischaemic stroke (index event), up to 1 day. |
| 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. | Up to 3 months of follow-up after index event. |
| 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. | At first ever ischaemic stroke (index event), up to 1 day. |
| 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. | Up to 3 months of follow-up after index event. |
| 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. | Up to 3 months of follow-up after index event. |
| COMPLETED |
|
| NOT COMPLETED |
|
Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Total | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke based on existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. |
| 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 |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 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 | 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. | 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. | Posted | Number | Percentage of participants | Up to 3 months of follow-up after index event |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Median | Inter-Quartile Range | Score on a scale | At first ever ischaemic stroke (index event) date, up to 1 day. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Median | Inter-Quartile Range | Score on a scale | At first ever ischaemic stroke (index event) date, up to 1 day. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Years | At first ever ischaemic stroke (index event), up to 1 day. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | millimetre of mercury (mm Hg) | At first ever ischaemic stroke (index event), up to 1 day. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Median | Inter-Quartile Range | Score on a scale | At first ever ischaemic stroke (index event), up to 1 day. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Median | Inter-Quartile Range | Score on a scale | At first ever ischaemic stroke (index event), up to 1 day. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | Percentage of participants | At first ever ischaemic stroke (index event), up to 1 day. |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | Times | Up to 3 months of follow-up after index event. |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | Times | At first ever ischaemic stroke (index event), up to 1 day. |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | Times | Up to 3 months of follow-up after index event. |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | Times | Up to 3 months of follow-up after index event. |
|
|
Adverse event information was not applicable for this study.
As this is a observational study with existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry, safety monitoring and safety reporting on an individual case level is not applicable.
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 | Total | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke based on existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
This is an observational study on existing data. All findings are conditional on a selected sample of subjects who had initiated treatment prior to dying, having a second stroke or leaving care.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results.
Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days.
BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2018 | Jun 9, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| > 7 - 14 d |
|
| > 14 - 28 d |
|
| > 28 d - 3 months |
|
| > 24 - 72 Hours |
Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group. |
| OG002 | > 3 - 7 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group. |
| OG003 | > 7 - 14 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group. |
| OG004 | > 14 - 28 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group. |
| OG005 | > 28 Days - 3 Months | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group. |
|
|
|
| OG001 | > 24 - 72 Hours | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group. |
| OG002 | > 3 - 7 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group. |
| OG003 | > 7 - 14 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group. |
| OG004 | > 14 - 28 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group. |
| OG005 | > 28 Days - 3 Months | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group. |
|
|
|
| OG001 |
| > 24 - 72 Hours |
Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group. |
| OG002 | > 3 - 7 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group. |
| OG003 | > 7 - 14 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group. |
| OG004 | > 14 - 28 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group. |
| OG005 | > 28 Days - 3 Months | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group. |
|
|
|
| OG002 | > 3 - 7 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group. |
| OG003 | > 7 - 14 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group. |
| OG004 | > 14 - 28 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group. |
| OG005 | > 28 Days - 3 Months | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group. |
|
|
|
| OG001 |
| > 24 - 72 Hours |
Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group. |
| OG002 | > 3 - 7 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group. |
| OG003 | > 7 - 14 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group. |
| OG004 | > 14 - 28 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group. |
| OG005 | > 28 Days - 3 Months | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group. |
|
|
|
Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.
Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.
| OG002 | > 3 - 7 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group. |
| OG003 | > 7 - 14 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group. |
| OG004 | > 14 - 28 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group. |
| OG005 | > 28 Days - 3 Months | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group. |
|
|
|
| OG002 | > 3 - 7 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group. |
| OG003 | > 7 - 14 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group. |
| OG004 | > 14 - 28 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group. |
| OG005 | > 28 Days - 3 Months | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group. |
|
|
|
|
| OG002 | > 3 - 7 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group. |
| OG003 | > 7 - 14 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group. |
| OG004 | > 14 - 28 Days | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group. |
| OG005 | > 28 Days - 3 Months | Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group. |
|
|
|
|