Comparison · NCT00433966-f8d39618
Pharmacology Arm - Bivalirudin vs Pharmacology Arm - Unfractionated Heparin: Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Pharmacology Arm - Bivalirudin vs Pharmacology Arm - Unfractionated Heparin: Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events. Trial comparisons, record NCT00433966-f8d39618. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00433966-f8d39618
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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 | 0.0922 | 0.0797 | 0.106 | wilson | |
| Risk in group 2 | 0.121 | 0.107 | 0.137 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0288 | -0.049 | -0.0086 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.762 | 0.63 | 0.923 | log | |
| Odds ratio, group 1 over group 2 | 0.738 | 0.596 | 0.914 | log | |
| Number needed to treat, for one fewer participant with the outcome on Pharmacology Arm - Bivalirudin than on Pharmacology Arm - Unfractionated Heparin | 34.8 | 20.4 | 116 | 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 | Pharmacology Arm - Bivalirudin | To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~1. reduced rates of major bleeding events at 30 days~2. similar rates of major adverse ischemic cardiac events at 30 days~3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room). | 166 | 1,800 | OG000 |
| Group 2 | Pharmacology Arm - Unfractionated Heparin | To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~1. reduced rates of major bleeding events at 30 days~2. similar rates of major adverse ischemic cardiac events at 30 days~3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room). | 218 | 1,802 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events
- Description
Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) and major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting).
- Time frame
- 30 Days
- Population
Source ClinicalTrials.gov
Trial
- Title
- Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction
- NCT number
- NCT00433966
- Phases
- PHASE3
- Conditions
- Myocardial Infarction
- Interventions
- Bivalirudin, Unfractionated heparin, Bare metal stent, Paclitaxel-eluting stent
- Lead sponsor
- Cardiovascular Research Foundation, New York
- Results first posted
- 2017-12-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00433966?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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