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NCT01877915 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 5,081
- Enrollment target
NCT01877915: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT01877915 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 5,081 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (558% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01877915, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5,081 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.
Primary Outcome
Event Rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 patient \[pt\]-year \[yr\]) = 100\*n/(total risk exposure), where n is the number of events.
Interventions
- DRUG Placebo
- DRUG Rivaroxaban
- OTHER Standard of care for heart failure and coronary artery disease
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,081 participants |
| Start Date | 2013-09-10 |
| Est. Completion | 2018-04-19 |
| Phase | Phase 3 |
What the finished NCT01877915 record still lists
NCT01877915 is an interventional study that assigns participants to a tested intervention. Its 5,081 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 (558% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01877915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01877915 about?
NCT01877915 is a clinical study titled "A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure". The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensa...
What is the current status of trial NCT01877915?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,081 participants. The study started on 2013-09-10. Estimated completion is 2018-04-19.
What interventions are being tested in trial NCT01877915?
The interventions under investigation include: Placebo (DRUG), Rivaroxaban (DRUG), Standard of care for heart failure and coronary artery disease (OTHER).
Who is sponsoring clinical trial NCT01877915?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01877915's enrollment target sits among peer trials
5,081 48th of 2000 higher than 1,953 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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