Comparison · NCT00790907-3221f97a
OL Fondaparinux Background + Low Dose UFH During PCI vs OL Fondaparinux Background + Standard Dose UFH During PCI: Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period
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. OL Fondaparinux Background + Low Dose UFH During PCI vs OL Fondaparinux Background + Standard Dose UFH During PCI: Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period. Trial comparisons, record NCT00790907-3221f97a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00790907-3221f97a
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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 | 0.0469 | 0.0355 | 0.0616 | wilson | |
| Risk in group 2 | 0.0579 | 0.045 | 0.0741 | wilson | |
| Risk difference, group 1 minus group 2 | -0.011 | -0.0308 | 0.00853 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.81 | 0.558 | 1.18 | log | |
| Odds ratio, group 1 over group 2 | 0.8 | 0.54 | 1.19 | log | |
| Number needed to treat, for one fewer participant with the outcome on OL Fondaparinux Background + Low Dose UFH During PCI than on OL Fondaparinux Background + Standard Dose UFH During PCI | 90.8 | 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 | OL Fondaparinux Background + Low Dose UFH During PCI | OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram \[U/kg\], which was not adjusted for planned glycoprotein \[GP\] IIb/IIIa use or activated clotting time \[ACT\]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization. | 48 | 1,024 | OG000 |
| Group 2 | OL Fondaparinux Background + Standard Dose UFH During PCI | OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT \[maximum two additional bolus doses\]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization. | 58 | 1,002 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period
- Description
The peri-percutaneous coronary intervention (peri-PCI) period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major and minor bleeding events were adjudicated by a blinded central independent adjudication committee (CIAC). Major vascular access site complications comprised large hematoma, pseudoaneurysm requiring treatment, aterio-venous fistula, or other vascular procedures related to the access site.
- Time frame
- Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
- Population
- Intent-to-Treat (ITT) Population: all randomized participants
Source ClinicalTrials.gov
Trial
- Title
- Fondaparinux Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS)
- NCT number
- NCT00790907
- Phases
- PHASE4
- Conditions
- Acute Coronary Syndrome
- Interventions
- fondaparinux background and standard dose UFH, Fondaparinux background and low dose heparin, Open label fondaparinux
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2011-06-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00790907?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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