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NCT02293395 · ClinicalTrials.gov registry record · Phase 2
A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 3,037
- Enrollment target
NCT02293395: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT02293395 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 3,037 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (2183% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02293395, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3,037 participants
- Enrollment target
Study Summary
The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction \[STEMI\] and non-ST-segment elevation acute coronary syndrome \[NSTE-ACS\]).
Primary Outcome
Non CABG-related TIMI clinically significant bleeding events are sum of non CABG-related TIMI major bleeding events, TIMI minor bleeding events and TIMI bleeding events requiring medical attention. Major: any symptomatic intracranial bleeding: clinically overt signs of hemorrhage with hemoglobin (Hb) drop of greater than or equal to (\>=)5 gram per deciliter (g/dl) (or absolute drop in hematocrit of \>=15%) and fatal bleeding (results in death within 7 days); Minor: clinically overt sign of hemo
Interventions
- DRUG Clopidogrel
- DRUG Rivaroxaban
- DRUG Ticagrelor
- DRUG Acetylsalicylic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,037 participants |
| Start Date | 2015-04-20 |
| Est. Completion | 2016-10-14 |
| Phase | Phase 2 |
What the finished NCT02293395 record still lists
NCT02293395 is an interventional study that assigns participants to a tested intervention. Its 3,037 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (2183% higher).
The record links to 0 conditions, and to 4 interventions - of which Clopidogrel is the first listed.
NCT02293395 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02293395 about?
NCT02293395 is a clinical study titled "A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome". The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent a...
What is the current status of trial NCT02293395?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3,037 participants. The study started on 2015-04-20. Estimated completion is 2016-10-14.
What interventions are being tested in trial NCT02293395?
The interventions under investigation include: Clopidogrel (DRUG), Rivaroxaban (DRUG), Ticagrelor (DRUG), Acetylsalicylic acid (DRUG).
Who is sponsoring clinical trial NCT02293395?
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 NCT02293395's enrollment target sits among peer trials
3,037 6th of 2000 higher than 1,995 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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