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NCT02348723 · ClinicalTrials.gov registry record · Phase 4
Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)
A Phase 4 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 678
- Enrollment target
NCT02348723: Completed Phase 4 study, sponsored by Boehringer Ingelheim.
NCT02348723 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 678 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (31% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02348723, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 678 participants
- Enrollment target
Study Summary
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospective, randomized, open label, blinded end point) active controlled study. Secondary objectives are to assess additional safety endpoints and efficacy in this clinical setting. It is not intended to assess confirmatory hypothesis, this is an exploratory study.
Primary Outcome
Major bleeds were defined according to the ISTH definition of a major bleed, as follows * Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or * Bleeding associated with a reduction in haemoglobin of at least 2 g/dL (1.24 mmol/L), or leading to transfusion of 2 or more units of blood or packed cells. and/or * Fatal bleed These are based on adjudicated
Interventions
- DRUG Warfarin
- DRUG Dabigatran Etexilate 150mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 678 participants |
| Start Date | 2015-04-28 |
| Est. Completion | 2016-11-14 |
| Phase | Phase 4 |
What the finished NCT02348723 record still lists
NCT02348723 is an interventional study that assigns participants to a tested intervention. The registered 678 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (31% higher).
The record links to 0 conditions, and to 2 interventions - of which Warfarin is the first listed.
NCT02348723 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02348723 about?
NCT02348723 is a clinical study titled "Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)". The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospec...
What is the current status of trial NCT02348723?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 678 participants. The study started on 2015-04-28. Estimated completion is 2016-11-14.
What interventions are being tested in trial NCT02348723?
The interventions under investigation include: Warfarin (DRUG), Dabigatran Etexilate 150mg (DRUG).
Who is sponsoring clinical trial NCT02348723?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02348723's enrollment target sits among peer trials
678 119th of 2000 higher than 1,882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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