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Trial record 11 of 333 for:    DABIGATRAN

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

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ClinicalTrials.gov Identifier: NCT03258645
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
SITS international registry, Karolinska University Hospital, Stockholm, Sweden
Information provided by (Responsible Party):
Boehringer Ingelheim

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.


Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Dabigatran

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Study Type : Observational
Actual Enrollment : 1489 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Actual Study Start Date : November 15, 2018
Actual Primary Completion Date : June 17, 2019
Actual Study Completion Date : June 17, 2019


Group/Cohort Intervention/treatment
Acute ischemic stroke
Non-valvular atrial fibrillation patients hospitalized with an acute ischemic stroke
Drug: Dabigatran
Oral anticoagulant (NOAC) thrombin inhibitor
Other Name: Pradaxa




Primary Outcome Measures :
  1. timing of dabigatran treatment initiation after a first ever ischaemic stroke (index event) in NVAF patients [ Time Frame: At Discharge and at 3 months after index event ]

Secondary Outcome Measures :
  1. Description of baseline characteristics for patients treated with dabigatran according to time of dabigatran initiation [ Time Frame: At index stroke date or shortly after (baseline) ]
  2. Description of self-reported factors important for physician's decision when to initiate dabigatran and which dabigatran dose is used in the post-ischemic stroke setting for secondary prevention of stroke and safety in NVAF [ Time Frame: At index stroke date or shortly after (baseline) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1000
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258645


Locations
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Sweden
SITS International (c/o Karolinska University Hospital)
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Boehringer Ingelheim
SITS international registry, Karolinska University Hospital, Stockholm, Sweden
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03258645     History of Changes
Other Study ID Numbers: 1160.235
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dabigatran
Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants