Comparison · NCT02556203-sae
Rivaroxaban Arm vs Antiplatelet Arm: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Rivaroxaban Arm vs Antiplatelet Arm: serious adverse events. Trial comparisons, record NCT02556203-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02556203-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.37 | 0.337 | 0.404 | wilson | |
| Risk in group 2 | 0.349 | 0.317 | 0.383 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0201 | -0.0268 | 0.0668 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.928 | 1.2 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.89 | 1.34 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Rivaroxaban Arm than on Antiplatelet Arm | 49.8 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rivaroxaban Arm | Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone. | 296 | 801 | EG000 |
| Group 2 | Antiplatelet Arm | Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone. | 282 | 807 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Source ClinicalTrials.gov
Trial
- Title
- Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
- NCT number
- NCT02556203
- Phases
- PHASE3
- Conditions
- Transcatheter Aortic Valve Replacement
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939), Acetylsalicylic Acid (ASA), Clopidogrel, Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonist (VKA)
- Lead sponsor
- Bayer
- Results first posted
- 2020-01-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02556203?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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