At a glance
ClinicalIndex Comparison RecordN/ACompleted· 3,182 enrolled
Drug / intervention
Pradaxa (Dabigatran etexilate mesilate)drug
Likely dose
Pradaxa (Dabigatran etexilate mesilate) 110 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
An observational study evaluating Pradaxa (Dabigatran etexilate mesilate) for Atrial Fibrillation. Completed, enrolled 3,182 participants across 1 site.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesSouth Korea
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2013
First PostedJan 2013
Primary CompletionFeb 2017
TodayJul 2026
First PostedJan 24, 2013
Enrollment StartJan 14, 2013
Primary CompletionFeb 17, 2017
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 13.4 years ago
Interventions
Pradaxa (Dabigatran etexilate mesilate)drug
110 mg or 150 mg b.i.d.