DAPPAR AF Dabigatran for Peri Procedural Anticoagulation During Radiofrequency Ablation of Atrial Fibrillation (DAPPARAF)
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|ClinicalTrials.gov Identifier: NCT01468155|
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: dabigatran||Phase 4|
All patients will be initiated on fixed dose Dabigatran 150 mg BID at least one month prior to the ablation procedure. If patients were already on warfarin therapy, then warfarin should be stopped for a minimum of 2 days prior to Dabigatran initiation, when the INR is less than 2. Patients will remain on the same dose of Dabigatran until the day before ablation. On the day prior to ablation, patients will not take any Dabigatran, nor will any be taken on the day of ablation, until after sheath removal.
For patients in high-risk groups for bleeding, the lower dose of Dabigatran may be used, or the drug may be stopped further in advance of the procedure. For patients with age greater than 80 years old, the lower dose of Dabigatran (110 mg BID) may be used as an alternative. For patients with impaired renal function, the lower dose may be used, but the drug may be stopped earlier in advance of the procedure as per the suggestions in Appendix A.
Post-ablation, Dabigatran will be started at the same dose - either 150 mg or 110 mg - as before the ablation procedure. Dabigatran will be initiated 8 hours post sheath removal and continue twice daily until the three month follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dabigatran for Peri Procedural Anticoagulation During Radiofrequency Ablation of Atrial Fibrillation|
|Actual Study Start Date :||July 13, 2011|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||June 7, 2017|
Active Comparator: Dabigatran
Dabigatran will be compared to historical data using other OAC methods for Pulmonary Vein Ablation
30 days pre ablation and 90 days post ablation
Other Name: pradax
- The incidence of peri-procedural major bleeding complications [ Time Frame: 1 month prior to Pulmonary Vein Ablation and three months post ablation. ]
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): NCT01468155
|London Health Sciences Center|
|London, Ontario, Canada, N6A 5A5|
|Principal Investigator:||Allan Skanes, MD, FRCPC||Lawson Health Research Institute|