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NCT01830543 · ClinicalTrials.gov registry record · Phase 3
A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention
A Phase 3 study, sponsored by Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,124
- Enrollment target
NCT01830543: Completed Phase 3 study, sponsored by Janssen Scientific Affairs.
NCT01830543 is a Phase 3 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 2,124 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (175% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01830543, a Phase 3 study, has completed, sponsored by Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,124 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).
Primary Outcome
Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (\>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of \>
Interventions
- DRUG rivaroxaban 2.5 mg
- DRUG rivaroxaban 15 mg
- DRUG rivaroxaban 10 mg
- DRUG aspirin (ASA)
- DRUG vitamin K antagonist (VKA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,124 participants |
| Start Date | 2013-05-10 |
| Est. Completion | 2016-07-28 |
| Phase | Phase 3 |
What the finished NCT01830543 record still lists
NCT01830543 is an interventional study that assigns participants to a tested intervention. Its 2,124 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 (175% higher).
The record links to 0 conditions, and to 5 interventions - of which rivaroxaban 2.5 mg is the first listed.
NCT01830543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01830543 about?
NCT01830543 is a clinical study titled "A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention". The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).
What is the current status of trial NCT01830543?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,124 participants. The study started on 2013-05-10. Estimated completion is 2016-07-28.
What interventions are being tested in trial NCT01830543?
The interventions under investigation include: rivaroxaban 2.5 mg (DRUG), rivaroxaban 15 mg (DRUG), rivaroxaban 10 mg (DRUG), aspirin (ASA) (DRUG), vitamin K antagonist (VKA) (DRUG).
Who is sponsoring clinical trial NCT01830543?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01830543's enrollment target sits among peer trials
2,124 98th of 2000 higher than 1,903 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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