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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,489 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Dabigatran	Oral anticoagulant (NOAC) thrombin inhibitor

Timeline

• Start date: 2018-11-15
• Primary completion: 2019-06-17
• Completion: 2019-06-17
• First posted: 2017-08-23
• Last updated: 2020-07-09
• Results posted: 2020-07-09

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated drug study