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

NCT03258645 | Completed Results FDA Drug

• 1 other identifier: 1160.235
• Study Type: observational
• Target: 1,489
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (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)

  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.

  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

  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

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

• Age 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 Dabigatran Initiation Time Period

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

• CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period

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

Study Arms (1)

Acute ischemic stroke

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

Drug: Dabigatran

Interventions

Dabigatran DRUG

Oral anticoagulant (NOAC) thrombin inhibitor

Also known as: Pradaxa

Acute ischemic stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1000

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

SITS International (c/o Karolinska University Hospital)

Stockholm, 171 76, Sweden

Location

Related Publications (1)

• 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.

  PMID: 32434935 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and 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.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: August 23, 2017
• Study Start: November 15, 2018
• Primary Completion: June 17, 2019
• Study Completion: June 17, 2019
• Last Updated: July 9, 2020
• Results First Posted: July 9, 2020

Record last verified: 2020-07

Locations

SE (1)