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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

Pradaxa Initiation Post-Stroke Study: SITS-Pradaxa 1. A Retrospective Analysis From the SITS-AF Registry on Treatment Initiation of Dabigatran Etexilate in Non-valvular Atrial Fibrillation Patients Hospitalized With Acute Ischemic Stroke

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03258645
Enrollment
1489
Registered
2017-08-23
Start date
2018-11-15
Completion date
2019-06-17
Last updated
2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

This is an observational study in patients with non-valvular atrial fibrillation (NVAF) presenting to the hospital with a first acute ischemic stroke based on existing data recorded in the SITS International Registry (located in Sweden) by physicians in several European countries, such as Italy, United Kingdom, Czech Republic, Sweden, Germany, Poland, Spain, Finland, Portugal, Slovakia, Denmark, Estonia, Norway Belgium, Hungary, Slovenia, Croatia, Austria, Lithuania, France, Greece, Netherlands, Ireland, Ukraine and Iceland. The aim of this study is to explore the current real world use of dabigatran for stroke prevention in NVAF patients in the post-stroke setting. Secondary data from eligible European patients registered in the SITS registry will be considered; countries of origin are not known a priori.

Interventions

DRUGDabigatran

Oral anticoagulant (NOAC) thrombin inhibitor

Sponsors

Karolinska University Hospital
CollaboratorOTHER
Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with non-valvular Atrial Fibrillation (NVAF) * Patients presenting with their first acute ischemic stroke * ≥18 years of age

Exclusion criteria

\- Documentation that the patient was enrolled or is planned to be enrolled in an investigational clinical trial at the time of the onset of the index event and for the duration of the data collection

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event)Up to 3 months of follow-up after index eventTo evaluate the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation (NVAF) after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke.

Secondary

MeasureTime frameDescription
National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time PeriodAt first ever ischaemic stroke (index event) date, up to 1 day.The National Institute of Health Stroke Scale (NIHSS) score on patients with non-valvular atrial fibrillation and dabigatran initiation timing information. The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke. Results were reported according to their dabigatran initiation timing categories.
Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time PeriodAt first ever ischaemic stroke (index event) date, up to 1 day.Previous Modified Rankin Scale (mRS) collected at first ever ischaemic stroke (index event). The Modified Rankin scale (mRS) is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome. Results were reported according to their dabigatran initiation timing categories.
Age of Patients According to Dabigatran Initiation Time PeriodAt first ever ischaemic stroke (index event), up to 1 day.Age of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. CHA2DS2-VASc and HAS-BLED were used in the statistical analysis. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/transient ischemic attack(TIA), Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalised ratio (INR), Elderly (\>65 years), Drugs and Alcohol Score.
Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time PeriodAt first ever ischaemic stroke (index event), up to 1 day.Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.
CHA2DS2-VASc of Patients According to Dabigatran Initiation Time PeriodAt first ever ischaemic stroke (index event), up to 1 day.The Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score of patients according to their start dabigatran time period. CHA2DS2-VASc is used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score ranges from 0 to 9 with 0 being the best outcome. Results were reported according to their dabigatran initiation timing categories.
HAS-BLED of Patients According to Dabigatran Initiation Time PeriodAt first ever ischaemic stroke (index event), up to 1 day.The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol (HAS-BLED) Score of patients according to their start dabigatran time period. HAS-BLED score ranges from 0 to 9 with higher scores indicating greater risk of bleeding. Results were reported according to their dabigatran initiation timing categories.
Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time PeriodAt first ever ischaemic stroke (index event), up to 1 day.Percentage of patients with History of or predisposition to bleeding according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Up to 3 months of follow-up after index event.Number of time the corresponding reason to delay oral anticoagulation (OAC) entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodAt first ever ischaemic stroke (index event), up to 1 day.Physicians' reason to delay dabigatran initiation according to their start dabigatran time period. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansUp to 3 months of follow-up after index event.Number of times of corresponding reason of choosing daily dosage of 220 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansUp to 3 months of follow-up after index event.Number of times the corresponding reason for choosing daily dosage of 300 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.

Countries

Sweden

Participant flow

Recruitment details

This retrospective study using existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry assessed the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation after the first ever ischemic stroke (3 months of follow-up thereafter) to prevent secondary stroke.

Pre-assignment details

In this non-interventional study based on existing data, no patients were screened.

Baseline characteristics

CharacteristicTotal
Age, Continuous75 Years
STANDARD_DEVIATION 10
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
788 Participants
Sex: Female, Male
Male
701 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

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.

Time frame: Up to 3 months of follow-up after index event

Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.

ArmMeasureGroupValue (NUMBER)
TotalPercentage 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 d33.1 Percentage of participants
TotalPercentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event)0 - 24 hours (h)5.9 Percentage of participants
TotalPercentage 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 h15.3 Percentage of participants
TotalPercentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event)> 3 - 7 days (d)27.7 Percentage of participants
TotalPercentage 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 d14.0 Percentage of participants
TotalPercentage 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 months4.0 Percentage of participants
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.

Time frame: At first ever ischaemic stroke (index event), up to 1 day.

Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.

ArmMeasureValue (MEAN)Dispersion
TotalAge of Patients According to Dabigatran Initiation Time Period72 YearsStandard Deviation 11
> 24 - 72 HoursAge of Patients According to Dabigatran Initiation Time Period74 YearsStandard Deviation 10
> 3 - 7 DaysAge of Patients According to Dabigatran Initiation Time Period75 YearsStandard Deviation 9
> 7 - 14 DaysAge of Patients According to Dabigatran Initiation Time Period75 YearsStandard Deviation 9
> 14 - 28 DaysAge of Patients According to Dabigatran Initiation Time Period76 YearsStandard Deviation 9
> 28 Days - 3 MonthsAge of Patients According to Dabigatran Initiation Time Period77 YearsStandard Deviation 10
Comparison: Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.p-value: 0.01695% CI: [1.02, 1.25]Regression, Linear
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.

Time frame: At first ever ischaemic stroke (index event), up to 1 day.

Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.

ArmMeasureValue (MEDIAN)
TotalCHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period5 Score on a scale
> 24 - 72 HoursCHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period5 Score on a scale
> 3 - 7 DaysCHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period5 Score on a scale
> 7 - 14 DaysCHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period5 Score on a scale
> 14 - 28 DaysCHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period5 Score on a scale
> 28 Days - 3 MonthsCHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period5 Score on a scale
Comparison: Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.p-value: 0.0495% CI: [1, 1.21]Regression, Linear
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.

Time frame: At first ever ischaemic stroke (index event), up to 1 day.

Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.

ArmMeasureValue (MEAN)Dispersion
TotalDiastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period87 millimetre of mercury (mm Hg)Standard Deviation 12
> 24 - 72 HoursDiastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period83 millimetre of mercury (mm Hg)Standard Deviation 15
> 3 - 7 DaysDiastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period84 millimetre of mercury (mm Hg)Standard Deviation 14
> 7 - 14 DaysDiastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period85 millimetre of mercury (mm Hg)Standard Deviation 15
> 14 - 28 DaysDiastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period85 millimetre of mercury (mm Hg)Standard Deviation 17
> 28 Days - 3 MonthsDiastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period91 millimetre of mercury (mm Hg)Standard Deviation 16
Comparison: Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.p-value: 0.00295% CI: [1.04, 1.21]Regression, Linear
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.

Time frame: At first ever ischaemic stroke (index event), up to 1 day.

Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.

ArmMeasureValue (MEDIAN)
TotalHAS-BLED of Patients According to Dabigatran Initiation Time Period3 Score on a scale
> 24 - 72 HoursHAS-BLED of Patients According to Dabigatran Initiation Time Period3 Score on a scale
> 3 - 7 DaysHAS-BLED of Patients According to Dabigatran Initiation Time Period3 Score on a scale
> 7 - 14 DaysHAS-BLED of Patients According to Dabigatran Initiation Time Period3 Score on a scale
> 14 - 28 DaysHAS-BLED of Patients According to Dabigatran Initiation Time Period3 Score on a scale
> 28 Days - 3 MonthsHAS-BLED of Patients According to Dabigatran Initiation Time Period3 Score on a scale
Comparison: Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.p-value: 0.05195% CI: [0.45, 1]Regression, Linear
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.

Time frame: At first ever ischaemic stroke (index event) date, up to 1 day.

Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.

ArmMeasureValue (MEDIAN)
TotalNational Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period8 Score on a scale
> 24 - 72 HoursNational Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period8 Score on a scale
> 3 - 7 DaysNational Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period8 Score on a scale
> 7 - 14 DaysNational Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period12 Score on a scale
> 14 - 28 DaysNational Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period14 Score on a scale
> 28 Days - 3 MonthsNational Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period15 Score on a scale
Comparison: Univariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of National Institute of Health Stroke Scale (NIHSS) score at index date was applied.p-value: <0.001Regression, Linear
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.

Time frame: Up to 3 months of follow-up after index event.

Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.

ArmMeasureGroupValue (NUMBER)
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansHaemorrhagic transformation6 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansIntracranial Haemorrhage (ICH) spontaneous3 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansSeverity of stroke18 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansSize of infarct13 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansLocation of infarct8 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansIntervention used to treat stroke4 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansAltered coagulation parameters7 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansPatients bleeding risk6.3 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansPatients stroke risk27 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansRecommendation from specialist32 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansReason is not specified95 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansOther reasons10 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansPatients age209 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansCo-medication11 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansCo-morbidities16 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by PhysiciansRenal function48 Times
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.

Time frame: Up to 3 months of follow-up after index event.

Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.

ArmMeasureGroupValue (NUMBER)
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansIntracranial Haemorrhage (ICH) spontaneous1 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansSeverity of stroke38 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansSize of infarct16 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansLocation of infarct18 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansIntervention used to treat stroke3 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansAltered coagulation parameters10 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansPatients bleeding risk34 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansPatients stroke risk89 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansRecommendation from specialist50 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansReason is not specified216 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansOther reasons1 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansPatients age139 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansCo-medication5 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansCo-morbidities19 Times
TotalNumber of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by PhysiciansRenal function47 Times
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.

Time frame: At first ever ischaemic stroke (index event), up to 1 day.

Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.

ArmMeasureGroupValue (NUMBER)
TotalNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodHaemorrhagic transformation0 Times
TotalNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodIntracranial Haemorrhage (ICH) pontaneous0 Times
TotalNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodSeverity Infarct0 Times
TotalNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodSize of Infarct0 Times
TotalNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodLocation Infarct0 Times
TotalNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodIntervention used to treat ischemic stroke0 Times
TotalNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodAltered coagulation parameters0 Times
TotalNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPatients bleeding risk factors0 Times
TotalNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPatients stroke risk factors0 Times
TotalNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodRecommendation from specialist0 Times
TotalNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPractical considerations1 Times
TotalNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodReason is not specified0 Times
TotalNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodOther reasons0 Times
> 24 - 72 HoursNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodSeverity Infarct0 Times
> 24 - 72 HoursNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodOther reasons0 Times
> 24 - 72 HoursNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodHaemorrhagic transformation0 Times
> 24 - 72 HoursNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPatients bleeding risk factors1 Times
> 24 - 72 HoursNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPractical considerations1 Times
> 24 - 72 HoursNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodIntervention used to treat ischemic stroke0 Times
> 24 - 72 HoursNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodIntracranial Haemorrhage (ICH) pontaneous0 Times
> 24 - 72 HoursNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPatients stroke risk factors0 Times
> 24 - 72 HoursNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodReason is not specified0 Times
> 24 - 72 HoursNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodRecommendation from specialist0 Times
> 24 - 72 HoursNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodLocation Infarct0 Times
> 24 - 72 HoursNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodAltered coagulation parameters0 Times
> 24 - 72 HoursNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodSize of Infarct0 Times
> 3 - 7 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodAltered coagulation parameters0 Times
> 3 - 7 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPatients stroke risk factors0 Times
> 3 - 7 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPatients bleeding risk factors0 Times
> 3 - 7 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodSize of Infarct2 Times
> 3 - 7 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodSeverity Infarct1 Times
> 3 - 7 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodHaemorrhagic transformation2 Times
> 3 - 7 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodLocation Infarct0 Times
> 3 - 7 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodIntracranial Haemorrhage (ICH) pontaneous0 Times
> 3 - 7 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPractical considerations0 Times
> 3 - 7 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodIntervention used to treat ischemic stroke0 Times
> 3 - 7 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodReason is not specified1 Times
> 3 - 7 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodRecommendation from specialist0 Times
> 3 - 7 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodOther reasons0 Times
> 7 - 14 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPatients bleeding risk factors4 Times
> 7 - 14 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodSeverity Infarct7 Times
> 7 - 14 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodSize of Infarct9 Times
> 7 - 14 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodReason is not specified5 Times
> 7 - 14 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodLocation Infarct3 Times
> 7 - 14 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodIntervention used to treat ischemic stroke2 Times
> 7 - 14 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodAltered coagulation parameters2 Times
> 7 - 14 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPatients stroke risk factors2 Times
> 7 - 14 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodRecommendation from specialist0 Times
> 7 - 14 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodOther reasons0 Times
> 7 - 14 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPractical considerations0 Times
> 7 - 14 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodHaemorrhagic transformation2 Times
> 7 - 14 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodIntracranial Haemorrhage (ICH) pontaneous1 Times
> 14 - 28 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPatients stroke risk factors2 Times
> 14 - 28 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodIntervention used to treat ischemic stroke3 Times
> 14 - 28 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodRecommendation from specialist2 Times
> 14 - 28 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodSeverity Infarct12 Times
> 14 - 28 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodReason is not specified4 Times
> 14 - 28 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodIntracranial Haemorrhage (ICH) pontaneous3 Times
> 14 - 28 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPractical considerations3 Times
> 14 - 28 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodLocation Infarct2 Times
> 14 - 28 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodHaemorrhagic transformation8 Times
> 14 - 28 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodOther reasons1 Times
> 14 - 28 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPatients bleeding risk factors6 Times
> 14 - 28 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodAltered coagulation parameters1 Times
> 14 - 28 DaysNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodSize of Infarct12 Times
> 28 Days - 3 MonthsNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPractical considerations3 Times
> 28 Days - 3 MonthsNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPatients stroke risk factors1 Times
> 28 Days - 3 MonthsNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodReason is not specified1 Times
> 28 Days - 3 MonthsNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodIntervention used to treat ischemic stroke0 Times
> 28 Days - 3 MonthsNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodAltered coagulation parameters0 Times
> 28 Days - 3 MonthsNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodSeverity Infarct2 Times
> 28 Days - 3 MonthsNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodSize of Infarct3 Times
> 28 Days - 3 MonthsNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodRecommendation from specialist1 Times
> 28 Days - 3 MonthsNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodIntracranial Haemorrhage (ICH) pontaneous0 Times
> 28 Days - 3 MonthsNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodPatients bleeding risk factors0 Times
> 28 Days - 3 MonthsNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodLocation Infarct0 Times
> 28 Days - 3 MonthsNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodHaemorrhagic transformation1 Times
> 28 Days - 3 MonthsNumber of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time PeriodOther reasons0 Times
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.

Time frame: Up to 3 months of follow-up after index event.

Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.

ArmMeasureGroupValue (NUMBER)
TotalNumber of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Haemorrhagic transformation40 Times
TotalNumber of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Intracranial Haemorrhage (ICH) Spontaneous8 Times
TotalNumber of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Severity Infarct61 Times
TotalNumber of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Size of Infarct52 Times
TotalNumber of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Location Infarct14 Times
TotalNumber of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Intervention used to treat ischemic stroke8 Times
TotalNumber of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Altered coagulation parameters5 Times
TotalNumber of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Patients bleeding risk factors18 Times
TotalNumber of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Patients stroke risk factors6 Times
TotalNumber of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Patient preference4 Times
TotalNumber of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Recommendation from specialist6 Times
TotalNumber of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Practical considerations14 Times
TotalNumber of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Reason is not specified27 Times
TotalNumber of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.Other reasons5 Times
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.

Time frame: At first ever ischaemic stroke (index event), up to 1 day.

Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.

ArmMeasureValue (NUMBER)
TotalPercentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period2.1 Percentage of participants
> 24 - 72 HoursPercentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period1.1 Percentage of participants
> 3 - 7 DaysPercentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period3.0 Percentage of participants
> 7 - 14 DaysPercentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period3.0 Percentage of participants
> 14 - 28 DaysPercentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period1.8 Percentage of participants
> 28 Days - 3 MonthsPercentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period4.4 Percentage of participants
Comparison: Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.p-value: 0.02695% CI: [0.9, 0.93]Regression, Linear
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.

Time frame: At first ever ischaemic stroke (index event) date, up to 1 day.

Population: Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.

ArmMeasureValue (MEDIAN)
TotalPrevious Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period0 Score on a scale
> 24 - 72 HoursPrevious Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period0 Score on a scale
> 3 - 7 DaysPrevious Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period0 Score on a scale
> 7 - 14 DaysPrevious Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period0 Score on a scale
> 14 - 28 DaysPrevious Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period0 Score on a scale
> 28 Days - 3 MonthsPrevious Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period0 Score on a scale
Comparison: Univariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of Modified Rankin Scale (mRS) at index date was applied.p-value: 0.01Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026