A Phase 3 interventional study of dabigatran and placebo in Atrial Fibrillation and Thromboembolism, sponsored by Korea University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-12-10.
Sponsored by Korea University · Phase 3, Interventional, and Prevention
The purpose of this study is to investigate the appropriate duration of dabigatran use after radiofrequency catheter ablation for paroxysmal atrial fibrillation in patients with low thromboembolic risk. According to the most recent guideline, anticoagulation is recommended to continue at least 2 months after the procedure. However bleeding risk with anticoagulant is also problematic. Post-procedural thrombosis is considered due to acute inflammation or char formation at the site of ablation, and these reaction occurs mostly within 1 month after the procedure. Also, the risk of thromboembolism is low in patients with CHA2DS2-VASc score less than 1. The investigators hypothesized that dabigatran use for the first 1 month after the RFCA for patients with paroxysmal AF and low thromboembolic risk would be sufficient for efficacy and safety compared to conventional dabigatran use for 2 months.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 464 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Korea University is the lead sponsor of 64 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients taking dabigatran for 1 month after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.
Drug: dabigatran
The patients taking dabigatran for 2 months after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.
Drug: placebo
The rate of thromboembolic events
Time frame: 2 months
No study locations are listed for this record.
This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Korea University