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NCT01546883 · ClinicalTrials.gov registry record · Phase 4
Dabigatran's Effect on Changes in Atrial Fibrosis in Patients With Atrial Fibrillation
A Phase 4 study, sponsored by University of Utah.
- Terminated
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT01546883: Clinical Trial Phase 4 study, sponsored by University of Utah.
NCT01546883 is a Phase 4 study that was terminated before completion, run by University of Utah. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01546883, a Phase 4 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study includes treating patients with atrial fibrillation (AF) with Dabigatran, an anti-coagulant for a period of one year to see if there are any significant changes in the degree of left atrial structural remodeling in these patients. The investigators hypothesize that there will be a significant decrease in the degree of left atrial structural remodeling (fibrosis) in AF patients treated with dabigatran.
Primary Outcome
We will measure the change in percentage of fibrosis over a one-year period when drug is taken. We will calculate the results as percentage of fibrosis measured using MRI at 12 months minus the percentage of fibrosis measured using MRI at baseline to clarify if there is a decrease in fibrosis in the one year period.
Interventions
- DRUG Dabigatran etexilate (Pradaxa)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-12 |
| Phase | Phase 4 |
Why NCT01546883 stopped before completion
NCT01546883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Dabigatran etexilate (Pradaxa) is the first listed.
NCT01546883 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01546883 about?
NCT01546883 is a clinical study titled "Dabigatran's Effect on Changes in Atrial Fibrosis in Patients With Atrial Fibrillation". This study includes treating patients with atrial fibrillation (AF) with Dabigatran, an anti-coagulant for a period of one year to see if there are any significant changes in the degree of left atrial structural remodeling in these patients. The investigators hypothesize that there will be a signifi...
What is the current status of trial NCT01546883?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2012-02. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01546883?
The interventions under investigation include: Dabigatran etexilate (Pradaxa) (DRUG).
Who is sponsoring clinical trial NCT01546883?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01546883's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 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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