Treatment Convenience in Patients Treated With Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

671 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-13

Study Completion Date

2018-10-10

Brief Summary

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Describe patient and physician assessed factors for patient well-being when treated with Pradaxa for stroke and embolism prevention in atrial fibrillation either compared to previous antithrombotic treatment (switcher)

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dabigatran

Patients switched from vitamin K antagonist (VKA) to dabigatran

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Written informed consent prior to participation
* Female and male patients 18 years of age or older with a diagnosis of non-valvular atrial fibrillation.
* At least 6 months of continuous vitamin K antagonist (VKA) treatment for stroke prevention prior to baseline assessment.
* Patients switched to Pradaxa® according to Summary of Product Characteristics, therapeutic positioning report from Spanish competent authorities and visa from each autonomous community.

Exclusion Criteria

* Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC)
* Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in non-valvular atrial fibrillation.
* Current participation in any clinical trial of a drug or device

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No