Trial Outcomes & Findings for This Study Uses the SITS Registry to Find Out When Patients With a Heart Rhythm Disorder (Atrial Fibrillation) Start Treatment With Dabigatran After They Had a Stroke (NCT NCT03258645)
NCT ID: NCT03258645
Last Updated: 2020-07-09
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
1489 participants
Primary outcome timeframe
Up to 3 months of follow-up after index event
Results posted on
2020-07-09
Participant Flow
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.
In this non-interventional study based on existing data, no patients were screened.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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1489
|
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Overall Study
COMPLETED
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1489
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total
n=1489 Participants
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.
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|---|---|
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Age, Continuous
|
75 Years
STANDARD_DEVIATION 10 • n=1489 Participants
|
|
Sex: Female, Male
Female
|
788 Participants
n=1489 Participants
|
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Sex: Female, Male
Male
|
701 Participants
n=1489 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months of follow-up after index eventPopulation: 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.
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.
Outcome measures
| Measure |
Total
n=1240 Participants
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.
|
> 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.
|
> 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.
|
> 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.
|
> 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.
|
> 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.
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|---|---|---|---|---|---|---|
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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)
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5.9 Percentage of participants
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—
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—
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—
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—
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—
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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
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—
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—
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—
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—
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—
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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)
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27.7 Percentage of participants
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—
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—
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—
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—
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—
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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
|
—
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—
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—
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—
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—
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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
|
—
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—
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—
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—
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—
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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
|
—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Total
n=73 Participants
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.
|
> 24 - 72 Hours
n=190 Participants
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.
|
> 3 - 7 Days
n=344 Participants
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.
|
> 7 - 14 Days
n=410 Participants
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.
|
> 14 - 28 Days
n=174 Participants
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.
|
> 28 Days - 3 Months
n=49 Participants
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.
|
|---|---|---|---|---|---|---|
|
National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
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8 Score on a scale
Interval 5.0 to 14.0
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8 Score on a scale
Interval 5.0 to 14.0
|
8 Score on a scale
Interval 6.0 to 13.0
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12 Score on a scale
Interval 7.0 to 17.0
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14 Score on a scale
Interval 10.0 to 18.0
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15 Score on a scale
Interval 9.0 to 19.0
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Total
n=73 Participants
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.
|
> 24 - 72 Hours
n=190 Participants
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.
|
> 3 - 7 Days
n=344 Participants
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.
|
> 7 - 14 Days
n=410 Participants
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.
|
> 14 - 28 Days
n=174 Participants
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.
|
> 28 Days - 3 Months
n=49 Participants
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.
|
|---|---|---|---|---|---|---|
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Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
|
0 Score on a scale
Interval 0.0 to 0.0
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0 Score on a scale
Interval 0.0 to 0.0
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0 Score on a scale
Interval 0.0 to 0.0
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0 Score on a scale
Interval 0.0 to 0.0
|
0 Score on a scale
Interval 0.0 to 0.0
|
0 Score on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Total
n=73 Participants
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.
|
> 24 - 72 Hours
n=190 Participants
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.
|
> 3 - 7 Days
n=344 Participants
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.
|
> 7 - 14 Days
n=410 Participants
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.
|
> 14 - 28 Days
n=174 Participants
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.
|
> 28 Days - 3 Months
n=49 Participants
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.
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|---|---|---|---|---|---|---|
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Age of Patients According to Dabigatran Initiation Time Period
|
72 Years
Standard Deviation 11
|
74 Years
Standard Deviation 10
|
75 Years
Standard Deviation 9
|
75 Years
Standard Deviation 9
|
76 Years
Standard Deviation 9
|
77 Years
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 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.
Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.
Outcome measures
| Measure |
Total
n=73 Participants
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.
|
> 24 - 72 Hours
n=190 Participants
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.
|
> 3 - 7 Days
n=344 Participants
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.
|
> 7 - 14 Days
n=410 Participants
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.
|
> 14 - 28 Days
n=174 Participants
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.
|
> 28 Days - 3 Months
n=49 Participants
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.
|
|---|---|---|---|---|---|---|
|
Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period
|
87 millimetre of mercury (mm Hg)
Standard Deviation 12
|
83 millimetre of mercury (mm Hg)
Standard Deviation 15
|
84 millimetre of mercury (mm Hg)
Standard Deviation 14
|
85 millimetre of mercury (mm Hg)
Standard Deviation 15
|
85 millimetre of mercury (mm Hg)
Standard Deviation 17
|
91 millimetre of mercury (mm Hg)
Standard Deviation 16
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Total
n=73 Participants
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.
|
> 24 - 72 Hours
n=190 Participants
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.
|
> 3 - 7 Days
n=344 Participants
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.
|
> 7 - 14 Days
n=410 Participants
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.
|
> 14 - 28 Days
n=174 Participants
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.
|
> 28 Days - 3 Months
n=49 Participants
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.
|
|---|---|---|---|---|---|---|
|
CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period
|
5 Score on a scale
Interval 4.0 to 6.0
|
5 Score on a scale
Interval 4.0 to 6.0
|
5 Score on a scale
Interval 4.0 to 6.0
|
5 Score on a scale
Interval 4.0 to 6.0
|
5 Score on a scale
Interval 4.0 to 6.0
|
5 Score on a scale
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Total
n=73 Participants
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.
|
> 24 - 72 Hours
n=190 Participants
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.
|
> 3 - 7 Days
n=344 Participants
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.
|
> 7 - 14 Days
n=410 Participants
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.
|
> 14 - 28 Days
n=174 Participants
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.
|
> 28 Days - 3 Months
n=49 Participants
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.
|
|---|---|---|---|---|---|---|
|
HAS-BLED of Patients According to Dabigatran Initiation Time Period
|
3 Score on a scale
Interval 2.0 to 3.0
|
3 Score on a scale
Interval 2.0 to 3.0
|
3 Score on a scale
Interval 2.0 to 3.0
|
3 Score on a scale
Interval 2.0 to 3.0
|
3 Score on a scale
Interval 2.0 to 3.0
|
3 Score on a scale
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Total
n=73 Participants
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.
|
> 24 - 72 Hours
n=190 Participants
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.
|
> 3 - 7 Days
n=344 Participants
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.
|
> 7 - 14 Days
n=410 Participants
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.
|
> 14 - 28 Days
n=174 Participants
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.
|
> 28 Days - 3 Months
n=49 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period
|
2.1 Percentage of participants
|
1.1 Percentage of participants
|
3.0 Percentage of participants
|
3.0 Percentage of participants
|
1.8 Percentage of participants
|
4.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Total
n=203 Participants
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.
|
> 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.
|
> 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.
|
> 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.
|
> 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.
|
> 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.
|
|---|---|---|---|---|---|---|
|
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Practical considerations
|
14 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Haemorrhagic transformation
|
40 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Intracranial Haemorrhage (ICH) Spontaneous
|
8 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Severity Infarct
|
61 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Size of Infarct
|
52 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Location Infarct
|
14 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Intervention used to treat ischemic stroke
|
8 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Altered coagulation parameters
|
5 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Patients bleeding risk factors
|
18 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Patients stroke risk factors
|
6 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Patient preference
|
4 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Recommendation from specialist
|
6 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Reason is not specified
|
27 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Other reasons
|
5 Times
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Total
n=1 Participants
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.
|
> 24 - 72 Hours
n=2 Participants
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.
|
> 3 - 7 Days
n=6 Participants
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.
|
> 7 - 14 Days
n=26 Participants
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.
|
> 14 - 28 Days
n=42 Participants
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.
|
> 28 Days - 3 Months
n=10 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Severity Infarct
|
0 Times
|
0 Times
|
1 Times
|
7 Times
|
12 Times
|
2 Times
|
|
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Intracranial Haemorrhage (ICH) pontaneous
|
0 Times
|
0 Times
|
0 Times
|
1 Times
|
3 Times
|
0 Times
|
|
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Haemorrhagic transformation
|
0 Times
|
0 Times
|
2 Times
|
2 Times
|
8 Times
|
1 Times
|
|
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Size of Infarct
|
0 Times
|
0 Times
|
2 Times
|
9 Times
|
12 Times
|
3 Times
|
|
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Location Infarct
|
0 Times
|
0 Times
|
0 Times
|
3 Times
|
2 Times
|
0 Times
|
|
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
|
0 Times
|
0 Times
|
2 Times
|
3 Times
|
0 Times
|
|
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Altered coagulation parameters
|
0 Times
|
0 Times
|
0 Times
|
2 Times
|
1 Times
|
0 Times
|
|
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Patients bleeding risk factors
|
0 Times
|
1 Times
|
0 Times
|
4 Times
|
6 Times
|
0 Times
|
|
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Patients stroke risk factors
|
0 Times
|
0 Times
|
0 Times
|
2 Times
|
2 Times
|
1 Times
|
|
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Recommendation from specialist
|
0 Times
|
0 Times
|
0 Times
|
0 Times
|
2 Times
|
1 Times
|
|
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Practical considerations
|
1 Times
|
1 Times
|
0 Times
|
0 Times
|
3 Times
|
3 Times
|
|
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Reason is not specified
|
0 Times
|
0 Times
|
1 Times
|
5 Times
|
4 Times
|
1 Times
|
|
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Other reasons
|
0 Times
|
0 Times
|
0 Times
|
0 Times
|
1 Times
|
0 Times
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Total
n=382 Participants
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.
|
> 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.
|
> 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.
|
> 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.
|
> 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.
|
> 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.
|
|---|---|---|---|---|---|---|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Haemorrhagic transformation
|
6 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Intracranial Haemorrhage (ICH) spontaneous
|
3 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Severity of stroke
|
18 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Size of infarct
|
13 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Location of infarct
|
8 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Intervention used to treat stroke
|
4 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Altered coagulation parameters
|
7 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Patients bleeding risk
|
6.3 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Patients stroke risk
|
27 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Recommendation from specialist
|
32 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Reason is not specified
|
95 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Other reasons
|
10 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Patients age
|
209 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Co-medication
|
11 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Co-morbidities
|
16 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Renal function
|
48 Times
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Total
n=475 Participants
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.
|
> 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.
|
> 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.
|
> 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.
|
> 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.
|
> 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.
|
|---|---|---|---|---|---|---|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Intracranial Haemorrhage (ICH) spontaneous
|
1 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Severity of stroke
|
38 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Size of infarct
|
16 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Location of infarct
|
18 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Intervention used to treat stroke
|
3 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Altered coagulation parameters
|
10 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Patients bleeding risk
|
34 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Patients stroke risk
|
89 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Recommendation from specialist
|
50 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Reason is not specified
|
216 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Other reasons
|
1 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Patients age
|
139 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Co-medication
|
5 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Co-morbidities
|
19 Times
|
—
|
—
|
—
|
—
|
—
|
|
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Renal function
|
47 Times
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Total
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER