Asundexian vs Apixaban: Number of Participants With Composite of CV Death, Stroke, or Myocardial Infarction (MI)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0209 | 0.0179 | 0.0244 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0104 | 0.00834 | 0.013 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.0105 | 0.00652 | 0.0146 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 2.01 | 1.53 | 2.63 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 2.03 | 1.54 | 2.67 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Asundexian than on Apixaban | 95.3 | 68.6 | 153 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | Asundexian | Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo. | 155 | 7,415 | OG000 | ClinicalTrials.gov |
| Group 2 | Apixaban | Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo. | 77 | 7,395 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With Composite of CV Death, Stroke, or Myocardial Infarction (MI) | ClinicalTrials.gov |
| Description | The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event.~The diagnosis of MI requires the combination of:~* Presence of acute myocardial injury (changes in cardiac biomarkers) and~* Evidence of acute myocardial ischemia derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging, or in case of post mortem pathological findings irrespective of biomarker values. | ClinicalTrials.gov |
| Time frame | Approximately 12 months | ClinicalTrials.gov |
| Population | aFAS | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke | ClinicalTrials.gov |
| NCT number | NCT05643573 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Prevention of Stroke or Systemic Embolism, Atrial Fibrillation | ClinicalTrials.gov |
| Interventions | Asundexian (BAY2433334), Apixaban, Asundexian matching placebo, Apixaban matching placebo | ClinicalTrials.gov |
| Lead sponsor | Bayer | ClinicalTrials.gov |
| Results first posted | 2024-12-09 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT05643573?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.