Comparison · NCT01087723-sae
Bivalirudin vs Standard of Care: Heparins With Optional GPI: 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. Bivalirudin vs Standard of Care: Heparins With Optional GPI: serious adverse events. Trial comparisons, record NCT01087723-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01087723-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 | 0.132 | 0.113 | 0.153 | wilson | |
| Risk in group 2 | 0.118 | 0.1 | 0.138 | wilson | |
| Risk difference, group 1 minus group 2 | 0.014 | -0.0137 | 0.0418 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 0.896 | 1.4 | log | |
| Odds ratio, group 1 over group 2 | 1.14 | 0.882 | 1.47 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Bivalirudin than on Standard of Care: Heparins With Optional GPI | 71.3 | 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 | Bivalirudin | Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator. | 145 | 1,099 | EG000 |
| Group 2 | Standard of Care: Heparins With Optional GPI | Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours \[maximum dose of 10 μg/min\]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI. | 129 | 1,094 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From screening to Day 30
Source ClinicalTrials.gov
Trial
- Title
- European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial
- NCT number
- NCT01087723
- Phases
- PHASE3
- Conditions
- Acute Coronary Syndrome
- Interventions
- Bivalirudin, Heparin
- Lead sponsor
- The Medicines Company
- Results first posted
- 2016-02-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01087723?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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