Asundexian vs Apixaban: Number of Participants With International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding
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 | 0.00231 | 0.00144 | 0.00369 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0072 | 0.00551 | 0.0094 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00489 | -0.00726 | -0.00271 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.32 | 0.186 | 0.553 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.319 | 0.184 | 0.551 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Asundexian than on Apixaban | 204 | 138 | 369 | 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. | 17 | 7,373 | 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. | 53 | 7,364 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants With International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding | ClinicalTrials.gov |
| Description | Assessment based on the (csHR), comparing asundexian with apixaban which is based on time to first event.~ISTH Major Bleeding was defined as an event that meets at least one of the below criteria, based on the definition given by the ISTH (Schulman and Kearon 2005):~* Fatal bleeding, and/or~* Symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular with compromised vision, pericardial, retroperitoneal, intra-articular, or intramuscular with compartment syndrome), and/or~* Clinically overt\* bleeding associated with a recent (within 48 hours) decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared with the most recent hemoglobin value available before the event, and/or~* Clinically overt\* bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood.~ * Overt bleeding required the identification of the bleeding location and the hemoglobin drop and/or transfusion needed to be related to the bleeding. | ClinicalTrials.gov |
| Time frame | Approximately 12 months | ClinicalTrials.gov |
| Population | Safety Analysis Set (SAF): All participants randomized to study intervention and who took at least 1 dose of study intervention. N=14757 Adjusted Safety Analysis Set (aSAF): All participants in the Safety Analysis Set excluding subjects randomized from one site in Japan. N=14737 Due to Good Clinical Practice violations, 20 participants from one site in Japan were excluded from all analyses.~aSAF population was analyzed for this outcome measure. | 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.