SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Pradaxa (Dabigatran Etexilate Mesilate, 110 mg or 150 mg b.i.d.) in Korean Patients With Non-valvular Atrial Fibrillation(SPARK: Safety Study of Pradaxa in AF Patients by Regulatory Requirement of Korea)|
- Occurrence of adverse events [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
- Incidence rate of stroke [ Time Frame: up to 26 weeks ] [ Designated as safety issue: Yes ]
- Incidence rate of systemic embolism [ Time Frame: up to 26 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||February 2017|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Drug: Pradaxa (Dabigatran etexilate mesilate)
110 mg or 150 mg b.i.d.
regulatory PMS study
|Contact: Boehringer Ingelheim Call Centerfirstname.lastname@example.org|
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|