SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea
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|ClinicalTrials.gov Identifier: NCT01774370|
Recruitment Status : Completed
First Posted : January 24, 2013
Results First Posted : March 8, 2019
Last Update Posted : March 8, 2019
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Drug: Pradaxa (Dabigatran etexilate mesilate)|
regulatory Post Marketed Surveillance study
|Study Type :||Observational|
|Actual Enrollment :||3182 participants|
|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)|
|Actual Study Start Date :||January 14, 2013|
|Actual Primary Completion Date :||February 17, 2017|
|Actual Study Completion Date :||February 17, 2017|
Drug: Pradaxa (Dabigatran etexilate mesilate)
110 mg or 150 mg b.i.d.
- 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) [ Time Frame: 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"
- Percentage of Participants With Stroke [ Time Frame: 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.
- Percentage of Participants With Systemic Embolism [ Time Frame: 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.
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): NCT01774370
|Korea, Republic of|
|Multiple Locations, Korea, Republic of|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|