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NCT01674647 · ClinicalTrials.gov registry record · Phase 3
Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,504
- Enrollment target
NCT01674647: Completed Phase 3 study, sponsored by Bayer.
NCT01674647 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 1,504 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01674647, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,504 participants
- Enrollment target
Study Summary
A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.
Primary Outcome
Stroke, TIA, Non-CNS Embolism, MI and cardiovascular death were adjudicated and confirmed by Clinical Endpoints Committee (CEC). Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves ap
Interventions
- DRUG Rivaroxaban (Xarelto, BAY59-7939)
- DRUG Vitamin K antagonist (VKA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,504 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT01674647 record still lists
NCT01674647 is an interventional study that assigns participants to a tested intervention. Its 1,504 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% higher).
The record links to 0 conditions, and to 2 interventions - of which Rivaroxaban (Xarelto, BAY59-7939) is the first listed.
NCT01674647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01674647 about?
NCT01674647 is a clinical study titled "Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion". A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure com...
What is the current status of trial NCT01674647?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,504 participants. The study started on 2012-10. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01674647?
The interventions under investigation include: Rivaroxaban (Xarelto, BAY59-7939) (DRUG), Vitamin K antagonist (VKA) (DRUG).
Who is sponsoring clinical trial NCT01674647?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01674647's enrollment target sits among peer trials
1,504 157th of 2000 higher than 1,844 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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