SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Pradaxa (Dabigatran etexilate mesilate)

• Registration Number: NCT01774370
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a prospective, non-interventional, open-label, multi-centre study. It will provide additional safety information of Pradaxa in Korean patients with non-valvular AF in clinical settings.

Detailed Description

Study Design:

regulatory Post Marketed Surveillance study

Study Timeline

• Study Start: 2013-01-14
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-21
• Study First Posted: 2013-01-24
• Primary Completion: 2017-02-17
• Study Completion: 2017-02-17
• Status Verified: 2018-02
• Results First Submitted: 2018-02-08
• Results First Submitted QC: 2018-11-10
• Last Update Submitted: 2018-11-10
• Results First Posted: 2019-03-08
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3182

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pradaxa group	Pradaxa (Dabigatran etexilate mesilate)	-

Primary Outcome Measures

Name	Time	Method
Occurrence of Adverse Events(Including Unexpected Adverse Events, Serious Adverse Events, Drug-related Adverse Events, Adverse Events Leading to Discontinuation and Adverse Events by Intensity, Outcome of the Event, Causality)	up to 26 weeks	Occurrence of adverse events(Including unexpected adverse events, serious adverse events, drug-related adverse events, adverse events leading to discontinuation and adverse events by intensity, outcome of the event, causality).; Number analyzed presents the "Number of participants with Adverse events"

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Systemic Embolism	up to 26 weeks	Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy.
Percentage of Participants With Stroke	up to 26 weeks	Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction.