Comparison · NCT02556203-15f52e7c
Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds
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 (Xarelto, BAY59-7939) vs Antiplatelet: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds. Trial comparisons, record NCT02556203-15f52e7c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02556203-15f52e7c
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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 | 0.0593 | 0.0452 | 0.0776 | wilson | |
| Risk in group 2 | 0.0367 | 0.0258 | 0.0519 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0226 | 0.00187 | 0.0439 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.62 | 1.04 | 2.52 | log | |
| Odds ratio, group 1 over group 2 | 1.66 | 1.04 | 2.64 | log | |
| Number needed to treat, for one more participant with the outcome on Rivaroxaban (Xarelto, BAY59-7939) than on Antiplatelet | 44.2 | 22.8 | 533 | from the risk difference interval |
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 (Xarelto, BAY59-7939) | Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (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. | 49 | 826 | OG000 |
| Group 2 | Antiplatelet | 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. | 30 | 818 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds
- Description
- ISTH major bleeds
- Time frame
- Through study completion, on average 16 months
- Population
- Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).
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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