Clinical trial NCT03258645: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Karolinska University Hospital
First posted: 2017-08-23
Enrollment: 1489
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000

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.


Eligibility criteria: 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

Primary outcomes:
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)
timeFrame: Up to 3 months of follow-up after index event
Secondary outcomes:
measure: National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
timeFrame: At first ever ischaemic stroke (index event) date, up to 1 day.
measure: Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
timeFrame: At first ever ischaemic stroke (index event) date, up to 1 day.
measure: Age of Patients According to Dabigatran Initiation Time Period
timeFrame: At first ever ischaemic stroke (index event), up to 1 day.
measure: Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period
timeFrame: At first ever ischaemic stroke (index event), up to 1 day.
measure: CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period
timeFrame: At first ever ischaemic stroke (index event), up to 1 day.
measure: HAS-BLED of Patients According to Dabigatran Initiation Time Period
timeFrame: At first ever ischaemic stroke (index event), up to 1 day.
measure: Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period
timeFrame: At first ever ischaemic stroke (index event), up to 1 day.
measure: Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
timeFrame: Up to 3 months of follow-up after index event.
measure: Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
timeFrame: At first ever ischaemic stroke (index event), up to 1 day.
measure: Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
timeFrame: Up to 3 months of follow-up after index event.
measure: Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
timeFrame: Up to 3 months of follow-up after index event.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: SITS International (c/o Karolinska University Hospital)
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.