This Study Uses the SITS Registry to Find Out When Patients With a Heart Rhythm Disorder (Atrial Fibrillation) Start Treatment With Dabigatran After They Had a Stroke

NCT ID: NCT03258645

Last Updated: 2020-07-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1489 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-15

Study Completion Date

2019-06-17

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Acute ischemic stroke

Non-valvular atrial fibrillation patients hospitalized with an acute ischemic stroke

Dabigatran

Intervention Type DRUG

Oral anticoagulant (NOAC) thrombin inhibitor

Interventions

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Dabigatran

Oral anticoagulant (NOAC) thrombin inhibitor

Intervention Type DRUG

Other Intervention Names

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Pradaxa

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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SITS International (c/o Karolinska University Hospital)

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 32434935 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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1160.235

Identifier Type: -

Identifier Source: org_study_id

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