Atrial FibrillationNCT03258645
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
An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Dabigatran
- Type of treatment
- Pill or oral medicine
- How many people
- 1,489 participants
- Where
- 1 siteSweden
- Study dates
- 15 Nov 2018to 17 Jun 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1000
Who may be able to join
- Patients with non-valvular Atrial Fibrillation (NVAF)
- Patients presenting with their first acute ischemic stroke
- ≥18 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
SITS International (c/o Karolinska University Hospital)
Stockholm, 171 76
About this study
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
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Dabigatran
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabigatranDrug
Also called Pradaxa
Oral anticoagulant (NOAC) thrombin inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke | Non-valvular atrial fibrillation patients hospitalized with an acute ischemic stroke Receives: Drug: Dabigatran |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months of follow-up after index event
Secondary outcomes (11)
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.
Measured: At first ever ischaemic stroke (index event) date, up to 1 day.
Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
Previous Modified Rankin Scale (mRS) collected at first ever ischaemic stroke (index event). The Modified Rankin scale (mRS) is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome. Results were reported according to their dabigatran initiation timing categories.
Measured: At first ever ischaemic stroke (index event) date, up to 1 day.
Age of Patients According to Dabigatran Initiation Time Period
Age of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. CHA2DS2-VASc and HAS-BLED were used in the statistical analysis. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/transient ischemic attack(TIA), Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalised ratio (INR), Elderly (>65 years), Drugs and Alcohol Score.
Measured: At first ever ischaemic stroke (index event), up to 1 day.
Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period
Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.
Measured: At first ever ischaemic stroke (index event), up to 1 day.
CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period
The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score of patients according to their start dabigatran time period. CHA2DS2-VASc is used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score ranges from 0 to 9 with 0 being the best outcome. Results were reported according to their dabigatran initiation timing categories.
Measured: At first ever ischaemic stroke (index event), up to 1 day.
HAS-BLED of Patients According to Dabigatran Initiation Time Period
The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED) Score of patients according to their start dabigatran time period. HAS-BLED score ranges from 0 to 9 with higher scores indicating greater risk of bleeding. Results were reported according to their dabigatran initiation timing categories.
Measured: At first ever ischaemic stroke (index event), up to 1 day.
Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period
Percentage of patients with History of or predisposition to bleeding according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.
Measured: At first ever ischaemic stroke (index event), up to 1 day.
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Number of time the corresponding reason to delay oral anticoagulation (OAC) entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Measured: Up to 3 months of follow-up after index event.
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Physicians' reason to delay dabigatran initiation according to their start dabigatran time period. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Measured: At first ever ischaemic stroke (index event), up to 1 day.
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Number of times of corresponding reason of choosing daily dosage of 220 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Measured: Up to 3 months of follow-up after index event.
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Number of times the corresponding reason for choosing daily dosage of 300 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Measured: Up to 3 months of follow-up after index event.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start15 Nov 2018
- Primary completion17 Jun 2019
- Study completion17 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258645
- Sponsor's protocol ID
- 1160.235
- Status last verified
- Jul 2020
- First submitted
- 18 Jul 2017
- Last updated
- 9 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Escudero-Martinez I, Mazya M, Teutsch C, Lesko N, Gdovinova Z, Barbarini L, Fryze W, Karlinski M, Kobayashi A, Krastev G, Paiva Nunes A, Pasztoova K, Peeters A, Sobolewski P, Vilionskis A, Toni D, Ahmed N; SITS Investigators. Dabigatran initiation in patients with non-valvular AF and first acute ischaemic stroke: a retrospective observational study from the SITS registry. BMJ Open. 2020 May 19;10(5):e037234. doi: 10.1136/bmjopen-2020-037234.
PubMed 32434935
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03258645
- Acronym / sponsor ID
- 1160.235
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,489 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Posted 9 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke | – | Drug: DabigatranNon-valvular atrial fibrillation patients hospitalized with an acute ischemic stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1000
Key inclusion criteria (3 listed)
- Patients with non-valvular Atrial Fibrillation (NVAF)
- Patients presenting with their first acute ischemic stroke
- ≥18 years of age
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DabigatranAlso: PradaxaOral anticoagulant (NOAC) thrombin inhibitor | Drug | Acute ischemic stroke |
Primary outcome
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)
Time frame: 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.
11 secondary outcomes
National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
Time frame: At first ever ischaemic stroke (index event) date, up to 1 day.
Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
Time frame: At first ever ischaemic stroke (index event) date, up to 1 day.
Age of Patients According to Dabigatran Initiation Time Period
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
HAS-BLED of Patients According to Dabigatran Initiation Time Period
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Time frame: Up to 3 months of follow-up after index event.
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Time frame: Up to 3 months of follow-up after index event.
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Time frame: Up to 3 months of follow-up after index event.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32434935Escudero-Martinez I, Mazya M, Teutsch C, Lesko N, Gdovinova Z, Barbarini L, Fryze W, Karlinski M, Kobayashi A, Krastev G, Paiva Nunes A, Pasztoova K, Peeters A, Sobolewski P, Vilionskis A, Toni D, Ahmed N; SITS Investigators. Dabigatran initiation in patients with non-valvular AF and first acute ischaemic stroke: a retrospective observational study from the SITS registry. BMJ Open. 2020 May 19;10(5):e037234. doi: 10.1136/bmjopen-2020-037234.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Up to 3 months of follow-up after index event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03258645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020; AzTrials last refreshed its copy on 30 Oct 2026.