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NCT01776424 · ClinicalTrials.gov registry record · Phase 3
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 27,395
- Enrollment target
NCT01776424: Completed Phase 3 study, sponsored by Bayer.
NCT01776424 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 27,395 participants, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (3458% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01776424, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 27,395 participants
- Enrollment target
Study Summary
The primary objectives of this study are: * To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); * To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.
Primary Outcome
Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Interventions
- DRUG Aspirin
- DRUG Rivaroxaban (Xarelto, BAY59-7939)
- DRUG Aspirin placebo
- DRUG Rivaroxaban placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27,395 participants |
| Start Date | 2013-02-28 |
| Est. Completion | 2021-06-15 |
| Phase | Phase 3 |
What the finished NCT01776424 record still lists
NCT01776424 is an interventional study that assigns participants to a tested intervention. Its 27,395 participants enrollment target places it among the larger protocols in the corpus, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (3458% higher).
The record links to 0 conditions, and to 4 interventions - of which Aspirin is the first listed.
NCT01776424 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01776424 about?
NCT01776424 is a clinical study titled "Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease". The primary objectives of this study are: * To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (...
What is the current status of trial NCT01776424?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 27,395 participants. The study started on 2013-02-28. Estimated completion is 2021-06-15.
What interventions are being tested in trial NCT01776424?
The interventions under investigation include: Aspirin (DRUG), Rivaroxaban (Xarelto, BAY59-7939) (DRUG), Aspirin placebo (DRUG), Rivaroxaban placebo (DRUG).
Who is sponsoring clinical trial NCT01776424?
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 NCT01776424's enrollment target sits among peer trials
27,395 6th of 2000 higher than 1,995 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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