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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03258645
• Collaborator: SITS international registry, Karolinska University Hospital, Stockholm, Sweden (Other)
• Enrollment: 1,489
• Location: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 211.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Dabigatran

Study Design

• Study Type: Observational
• Actual Enrollment: 1489 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: 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
• Actual Study Start Date: Nov 15, 2018
• Actual Primary Completion Date: Jun 17, 2019
• Actual Study Completion Date: Jun 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Acute ischemic stroke Non-valvular atrial fibrillation patients hospitalized with an acute ischemic stroke	Drug: Dabigatran; Oral anticoagulant (NOAC) thrombin inhibitor; Other Names: Pradaxa

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event) [Up to 3 months of follow-up after index event]

   To evaluate the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation (NVAF) after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke.

Secondary Outcome Measures

1. National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period [At first ever ischaemic stroke (index event) date, up to 1 day.]

   The National Institute of Health Stroke Scale (NIHSS) score on patients with non-valvular atrial fibrillation and dabigatran initiation timing information. The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke. Results were reported according to their dabigatran initiation timing categories.

2. Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period [At first ever ischaemic stroke (index event) date, up to 1 day.]

   Previous Modified Rankin Scale (mRS) collected at first ever ischaemic stroke (index event). The Modified Rankin scale (mRS) is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome. Results were reported according to their dabigatran initiation timing categories.

3. Age of Patients According to Dabigatran Initiation Time Period [At first ever ischaemic stroke (index event), up to 1 day.]

   Age of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. CHA2DS2-VASc and HAS-BLED were used in the statistical analysis. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/transient ischemic attack(TIA), Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalised ratio (INR), Elderly (>65 years), Drugs and Alcohol Score.

4. Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period [At first ever ischaemic stroke (index event), up to 1 day.]

   Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.

5. CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period [At first ever ischaemic stroke (index event), up to 1 day.]

   The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score of patients according to their start dabigatran time period. CHA2DS2-VASc is used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score ranges from 0 to 9 with 0 being the best outcome. Results were reported according to their dabigatran initiation timing categories.

6. HAS-BLED of Patients According to Dabigatran Initiation Time Period [At first ever ischaemic stroke (index event), up to 1 day.]

   The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED) Score of patients according to their start dabigatran time period. HAS-BLED score ranges from 0 to 9 with higher scores indicating greater risk of bleeding. Results were reported according to their dabigatran initiation timing categories.

7. Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period [At first ever ischaemic stroke (index event), up to 1 day.]

   Percentage of patients with History of or predisposition to bleeding according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.

8. 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.

9. Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period [At first ever ischaemic stroke (index event), up to 1 day.]

   Physicians' reason to delay dabigatran initiation according to their start dabigatran time period. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.

10. Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians [Up to 3 months of follow-up after index event.]

    Number of times of corresponding reason of choosing daily dosage of 220 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.

11. Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians [Up to 3 months of follow-up after index event.]

    Number of times the corresponding reason for choosing daily dosage of 300 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SITS International (c/o Karolinska University Hospital)	Stockholm		Sweden	171 76

Sponsors and Collaborators

• Boehringer Ingelheim
• SITS international registry, Karolinska University Hospital, Stockholm, Sweden

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

• Study Protocol - Jul 5, 2017
• Statistical Analysis Plan - Nov 7, 2018

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03258645
• Other Study ID Numbers: 1160.235
• First Posted: Aug 23, 2017
• Last Update Posted: Jul 9, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation; Dabigatran

Study Results

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

Arm/Group Title	Total
Arm/Group Description	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.
Period Title: Overall Study
STARTED	1489
COMPLETED	1489
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Total
Arm/Group Description	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.
Overall Participants	1489
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	75 (10)
Sex: Female, Male (Count of Participants)
Female	788 52.9%
Male	701 47.1%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	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)
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Total
Arm/Group Description	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.
Measure Participants	1240
0 - 24 hours (h)	5.9 0.4%
> 24 - 72 h	15.3 1%
> 3 - 7 days (d)	27.7 1.9%
> 7 - 14 d	33.1 2.2%
> 14 - 28 d	14.0 0.9%
> 28 d - 3 months	4.0 0.3%

2. Secondary Outcome

Title	National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	0 - 24 Hours	> 24 - 72 Hours	> 3 - 7 Days	> 7 - 14 Days	> 14 - 28 Days	> 28 Days - 3 Months
Arm/Group Description	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 less than 24 hours following index event were included in this group.	Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.	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.	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.	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.	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.
Measure Participants	73	190	344	410	174	49
Median (Inter-Quartile Range) [Score on a scale]	8	8	8	12	14	15

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Total, > 24 - 72 Hours, > 3 - 7 Days, > 7 - 14 Days, > 14 - 28 Days, > 28 Days - 3 Months
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Regression, Linear
	Comments

3. Secondary Outcome

Title	Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	0 - 24 Hours	> 24 - 72 Hours	> 3 - 7 Days	> 7 - 14 Days	> 14 - 28 Days	> 28 Days - 3 Months
Arm/Group Description	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 less than 24 hours following index event were included in this group.	Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.	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.	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.	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.	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.
Measure Participants	73	190	344	410	174	49
Median (Inter-Quartile Range) [Score on a scale]	0	0	0	0	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Total, > 24 - 72 Hours, > 3 - 7 Days, > 7 - 14 Days, > 14 - 28 Days, > 28 Days - 3 Months
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Regression, Linear
	Comments

4. Secondary Outcome

Title	Age of Patients According to Dabigatran Initiation Time Period
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	0 - 24 Hours	> 24 - 72 Hours	> 3 - 7 Days	> 7 - 14 Days	> 14 - 28 Days	> 28 Days - 3 Months
Arm/Group Description	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 less than 24 hours following index event were included in this group.	Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.	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.	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.	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.	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.
Measure Participants	73	190	344	410	174	49
Mean (Standard Deviation) [Years]	72 (11)	74 (10)	75 (9)	75 (9)	76 (9)	77 (10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Total, > 24 - 72 Hours, > 3 - 7 Days, > 7 - 14 Days, > 14 - 28 Days, > 28 Days - 3 Months
	Comments	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.
	Type of Statistical Test	Other
	Comments	CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/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 INR, Elderly (>65 years), Drugs and Alcohol Score.
Statistical Test of Hypothesis	p-Value	0.016
	Comments
	Method	Regression, Linear
	Comments	Relation between age and dabigatran initiation time was reported.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 1.02 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	0 - 24 Hours	> 24 - 72 Hours	> 3 - 7 Days	> 7 - 14 Days	> 14 - 28 Days	> 28 Days - 3 Months
Arm/Group Description	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 less than 24 hours following index event were included in this group.	Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.	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.	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.	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.	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.
Measure Participants	73	190	344	410	174	49
Mean (Standard Deviation) [millimetre of mercury (mm Hg)]	87 (12)	83 (15)	84 (14)	85 (15)	85 (17)	91 (16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Total, > 24 - 72 Hours, > 3 - 7 Days, > 7 - 14 Days, > 14 - 28 Days, > 28 Days - 3 Months
	Comments	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.
	Type of Statistical Test	Other
	Comments	CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/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 INR, Elderly (>65 years), Drugs and Alcohol Score.
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Regression, Linear
	Comments	Relation between Diastolic blood pressure (DBP) and dabigatran initiation time was reported.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95%; 1.04 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	0 - 24 Hours	> 24 - 72 Hours	> 3 - 7 Days	> 7 - 14 Days	> 14 - 28 Days	> 28 Days - 3 Months
Arm/Group Description	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 less than 24 hours following index event were included in this group.	Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.	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.	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.	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.	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.
Measure Participants	73	190	344	410	174	49
Median (Inter-Quartile Range) [Score on a scale]	5	5	5	5	5	5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Total, > 24 - 72 Hours, > 3 - 7 Days, > 7 - 14 Days, > 14 - 28 Days, > 28 Days - 3 Months
	Comments	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.
	Type of Statistical Test	Other
	Comments	CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/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 INR, Elderly (>65 years), Drugs and Alcohol Score.
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Regression, Linear
	Comments	Relation between CHA2DS2-VASc and dabigatran initiation time was reported.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 1.00 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	HAS-BLED of Patients According to Dabigatran Initiation Time Period
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	0 - 24 Hours	> 24 - 72 Hours	> 3 - 7 Days	> 7 - 14 Days	> 14 - 28 Days	> 28 Days - 3 Months
Arm/Group Description	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 less than 24 hours following index event were included in this group.	Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.	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.	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.	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.	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.
Measure Participants	73	190	344	410	174	49
Median (Inter-Quartile Range) [Score on a scale]	3	3	3	3	3	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Total, > 24 - 72 Hours, > 3 - 7 Days, > 7 - 14 Days, > 14 - 28 Days, > 28 Days - 3 Months
	Comments	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.
	Type of Statistical Test	Other
	Comments	CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/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 INR, Elderly (>65 years), Drugs and Alcohol Score.
Statistical Test of Hypothesis	p-Value	0.051
	Comments
	Method	Regression, Linear
	Comments	Relation between HAS-BLED and dabigatran initiation time was reported.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.45 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	0 - 24 Hours	> 24 - 72 Hours	> 3 - 7 Days	> 7 - 14 Days	> 14 - 28 Days	> 28 Days - 3 Months
Arm/Group Description	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 less than 24 hours following index event were included in this group.	Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.	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.	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.	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.	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.
Measure Participants	73	190	344	410	174	49
Number [Percentage of participants]	2.1 0.1%	1.1 NaN	3.0 NaN	3.0 NaN	1.8 NaN	4.4 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Total, > 24 - 72 Hours, > 3 - 7 Days, > 7 - 14 Days, > 14 - 28 Days, > 28 Days - 3 Months
	Comments	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.
	Type of Statistical Test	Other
	Comments	CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/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 INR, Elderly (>65 years), Drugs and Alcohol Score.
Statistical Test of Hypothesis	p-Value	0.026
	Comments
	Method	Regression, Linear
	Comments	Relation between History/Predisposition To Bleeding and dabigatran initiation time was reported.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.9 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Total
Arm/Group Description	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.
Measure Participants	203
Haemorrhagic transformation	40
Intracranial Haemorrhage (ICH) Spontaneous	8
Severity Infarct	61
Size of Infarct	52
Location Infarct	14
Intervention used to treat ischemic stroke	8
Altered coagulation parameters	5
Patients bleeding risk factors	18
Patients stroke risk factors	6
Patient preference	4
Recommendation from specialist	6
Practical considerations	14
Reason is not specified	27
Other reasons	5

10. Secondary Outcome

Title	Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	0 - 24 Hours	> 24 - 72 Hours	> 3 - 7 Days	> 7 - 14 Days	> 14 - 28 Days	> 28 Days - 3 Months
Arm/Group Description	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 less than 24 hours following index event were included in this group.	Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event. Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.	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.	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.	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.	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.
Measure Participants	1	2	6	26	42	10
Haemorrhagic transformation	0	0	2	2	8	1
Intracranial Haemorrhage (ICH) pontaneous	0	0	0	1	3	0
Severity Infarct	0	0	1	7	12	2
Size of Infarct	0	0	2	9	12	3
Location Infarct	0	0	0	3	2	0
Intervention used to treat ischemic stroke	0	0	0	2	3	0
Altered coagulation parameters	0	0	0	2	1	0
Patients bleeding risk factors	0	1	0	4	6	0
Patients stroke risk factors	0	0	0	2	2	1
Recommendation from specialist	0	0	0	0	2	1
Practical considerations	1	1	0	0	3	3
Reason is not specified	0	0	1	5	4	1
Other reasons	0	0	0	0	1	0

11. Secondary Outcome

Title	Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Total
Arm/Group Description	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.
Measure Participants	382
Haemorrhagic transformation	6
Intracranial Haemorrhage (ICH) spontaneous	3
Severity of stroke	18
Size of infarct	13
Location of infarct	8
Intervention used to treat stroke	4
Altered coagulation parameters	7
Patients bleeding risk	6.3
Patients stroke risk	27
Recommendation from specialist	32
Reason is not specified	95
Other reasons	10
Patients age	209
Co-medication	11
Co-morbidities	16
Renal function	48

12. Secondary Outcome

Title	Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Total
Arm/Group Description	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.
Measure Participants	475
Intracranial Haemorrhage (ICH) spontaneous	1
Severity of stroke	38
Size of infarct	16
Location of infarct	18
Intervention used to treat stroke	3
Altered coagulation parameters	10
Patients bleeding risk	34
Patients stroke risk	89
Recommendation from specialist	50
Reason is not specified	216
Other reasons	1
Patients age	139
Co-medication	5
Co-morbidities	19
Renal function	47

Adverse Events

Time Frame	Adverse event information was not applicable for this study.
Adverse Event Reporting Description	As this is a observational study with existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry, safety monitoring and safety reporting on an individual case level is not applicable.
Arm/Group Title	Total
Arm/Group Description	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.
All Cause Mortality
	Total
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Total
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Total
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

This is an observational study on existing data. All findings are conditional on a selected sample of subjects who had initiated treatment prior to dying, having a second stroke or leaving care.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.