Comparison · NCT04069156-a732e67a
Aspirin Arm (Principal Analysis Population) vs Placebo Arm (Principal Analysis Population): Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related 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. Aspirin Arm (Principal Analysis Population) vs Placebo Arm (Principal Analysis Population): Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events. Trial comparisons, record NCT04069156-a732e67a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04069156-a732e67a
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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 | 0.681 | 0.624 | 0.734 | wilson | |
| Risk in group 2 | 0.742 | 0.686 | 0.79 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0604 | -0.136 | 0.0158 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.919 | 0.825 | 1.02 | log | |
| Odds ratio, group 1 over group 2 | 0.745 | 0.513 | 1.08 | log | |
| Number needed to treat, for one fewer participant with the outcome on Aspirin Arm (Principal Analysis Population) than on Placebo Arm (Principal Analysis Population) | 16.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Aspirin Arm (Principal Analysis Population) | Patients randomized to the aspirin arm were given aspirin medication (100mg/day). | 186 | 273 | OG001 |
| Group 2 | Placebo Arm (Principal Analysis Population) | Patients randomized to the placebo arm were given placebo medication. | 201 | 271 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events
- Description
The primary end point was a composite of survival free of non-surgical major hemocompatibility related adverse events (specifically stroke, pump thrombosis, major non-surgical bleeding, and arterial peripheral thromboembolism) at 1-year post implant.
- Time frame
- 12 Months
- Population
The primary end point was analyzed in the principal analysis population, which excluded patients with events occurring within 14 days after LVAD implantation to avoid counting surgical complications not attributed to the treatment.
Source ClinicalTrials.gov
Trial
- Title
- The ARIES HeartMate 3 Pump IDE Study
- NCT number
- NCT04069156
- Phases
- NA
- Conditions
- Heart Failure
- Interventions
- LVAD Implant, Aspirin 100mg, Placebo oral tablet
- Lead sponsor
- Abbott Medical Devices
- Results first posted
- 2025-03-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04069156?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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