Trial · NCT00790907
Fondaparinux Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS)
NCT00790907, Phase 4, Completed, GlaxoSmithKline; results first posted 2011-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Fondaparinux Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS). Trials, record NCT00790907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00790907
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fondaparinux Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS)
- NCT number
- NCT00790907
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 3,235 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Acute Coronary Syndrome
- Interventions
- fondaparinux background and standard dose UFH, Fondaparinux background and low dose heparin, Open label fondaparinux
- First posted
- 2008-11-14
- Last updated
- 2017-03-23
- Results first posted
- 2011-06-07
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period | Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) | 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. |
| Secondary | Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30 | Peri-PCI period for major bleeding (during the time from randomization up to 48 hours after the end of PCI [typically 49 hours total] ) and from randomization up to Day 30 for death, MI, or TVR | The 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. Assessment of death, myocardial infarction (MI) and target vessel revascularisation (TVR) was performed at Day 30. Major bleeding, MI and TVR were adjudicated by a blinded CIAC. |
| Secondary | Number of Participants With Major Bleeding During the Peri-PCI Period | Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) | The 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 bleeding, MI and TVR were adjudicated by a blinded CIAC. |
| Secondary | Number of Participants With Minor Bleeding During the Peri-PCI Period | Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) | The 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. Minor bleeding events were adjudicated by a blinded CIAC. |
| Secondary | Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period | Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) | The 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 vascular access site complications included: large hematoma, pseudoaneurysm requiring treatment, arterio-venous fistula, or other vascular procedures related to the access site. |
| Secondary | Number of Participants With Major PCI-related Procedural Complications | During PCI procedure: immediately after randomization (approximately 10-75 minutes) | Major PCI-related procedural complications included: abrupt vessel closure, a new angiographic filling defect representing either angiographic thrombus or major dissection with reduced flow, no-reflow phenomenon, or catheter-related thrombus. Investigator reports of catheter-related thrombus were defined as suspected catheter-related thrombus events, and were adjudicated by a blinded CIAC. |
| Secondary | Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30 | Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30 | The 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. Assessment of composite of death, MI, or TVR was performed both during the peri-PCI period and at Day 30. MI and TVR events were adjudicated by a blinded CIAC. |
| Secondary | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30 | The 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. Assessment of death, MI, TVR, definite/probable stent thrombosis, or stroke was performed during the peri-PCI period and at Day 30. MI, TVR, definite/probable stent thrombosis, and stroke events were adjudicated by a blinded CIAC. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period | Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) | Intent-to-Treat (ITT) Population: all randomized participants | participants | NUMBER |
| SECONDARY | Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30 | Peri-PCI period for major bleeding (during the time from randomization up to 48 hours after the end of PCI [typically 49 hours total] ) and from randomization up to Day 30 for death, MI, or TVR | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Major Bleeding During the Peri-PCI Period | Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Minor Bleeding During the Peri-PCI Period | Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period | Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Major PCI-related Procedural Complications | During PCI procedure: immediately after randomization (approximately 10-75 minutes) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30 | Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30 | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 | Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30 | ITT Population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period | OL Fondaparinux Background + Low Dose UFH During PCI | 48 | participants | ||
| Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period | OL Fondaparinux Background + Standard Dose UFH During PCI | 58 | participants | ||
| Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30 | OL Fondaparinux Background + Low Dose UFH During PCI | 59 | participants | ||
| Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30 | OL Fondaparinux Background + Standard Dose UFH During PCI | 39 | participants | ||
| Number of Participants With Major Bleeding During the Peri-PCI Period | OL Fondaparinux Background + Low Dose UFH During PCI | 14 | participants | ||
| Number of Participants With Major Bleeding During the Peri-PCI Period | OL Fondaparinux Background + Standard Dose UFH During PCI | 12 | participants | ||
| Number of Participants With Minor Bleeding During the Peri-PCI Period | OL Fondaparinux Background + Low Dose UFH During PCI | 7 | participants | ||
| Number of Participants With Minor Bleeding During the Peri-PCI Period | OL Fondaparinux Background + Standard Dose UFH During PCI | 17 | participants | ||
| Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period | OL Fondaparinux Background + Low Dose UFH During PCI | 33 | participants | ||
| Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period | OL Fondaparinux Background + Standard Dose UFH During PCI | 43 | participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open-label Fondaparinux 2.5 mg | 1,209 | |
| Overall Study | STARTED | OL Fondaparinux Background + Low Dose UFH During PCI | 1,024 | |
| Overall Study | STARTED | OL Fondaparinux Background + Standard Dose UFH During PCI | 1,002 | |
| Overall Study | COMPLETED | Open-label Fondaparinux 2.5 mg | 754 | |
| Overall Study | COMPLETED | OL Fondaparinux Background + Low Dose UFH During PCI | 684 | |
| Overall Study | COMPLETED | OL Fondaparinux Background + Standard Dose UFH During PCI | 663 | |
| Overall Study | NOT COMPLETED | Open-label Fondaparinux 2.5 mg | 455 | |
| Overall Study | NOT COMPLETED | OL Fondaparinux Background + Low Dose UFH During PCI | 340 | |
| Overall Study | NOT COMPLETED | OL Fondaparinux Background + Standard Dose UFH During PCI | 339 |
Source ClinicalTrials.gov
Adverse events264
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Open-label Fondaparinux 2.5 mg | 18 | 1,209 | |
| other | Headache | Nervous system disorders | OL Fondaparinux Background + Low Dose UFH During PCI | 24 | 1,024 | |
| other | Headache | Nervous system disorders | OL Fondaparinux Background + Standard Dose UFH During PCI | 28 | 1,002 | |
| other | Gastritis | Gastrointestinal disorders | Open-label Fondaparinux 2.5 mg | 15 | 1,209 | |
| other | Gastritis | Gastrointestinal disorders | OL Fondaparinux Background + Low Dose UFH During PCI | 0 | 1,024 | |
| other | Gastritis | Gastrointestinal disorders | OL Fondaparinux Background + Standard Dose UFH During PCI | 2 | 1,002 | |
| other | Urinary tract infection | Infections and infestations | Open-label Fondaparinux 2.5 mg | 15 | 1,209 | |
| other | Urinary tract infection | Infections and infestations | OL Fondaparinux Background + Low Dose UFH During PCI | 5 | 1,024 | |
| other | Urinary tract infection | Infections and infestations | OL Fondaparinux Background + Standard Dose UFH During PCI | 5 | 1,002 | |
| other | Asthenia | General disorders | Open-label Fondaparinux 2.5 mg | 13 | 1,209 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-label Fondaparinux 2.5 mg | ||
| Total, all-cause mortality | OL Fondaparinux Background + Low Dose UFH During PCI | ||
| Total, all-cause mortality | OL Fondaparinux Background + Standard Dose UFH During PCI | ||
| Total, other adverse events | Open-label Fondaparinux 2.5 mg | 117 | 1,209 |
| Total, other adverse events | OL Fondaparinux Background + Low Dose UFH During PCI | 100 | 1,024 |
| Total, other adverse events | OL Fondaparinux Background + Standard Dose UFH During PCI | 113 | 1,002 |
| Total, serious adverse events | Open-label Fondaparinux 2.5 mg | 48 | 1,209 |
| Total, serious adverse events | OL Fondaparinux Background + Low Dose UFH During PCI | 28 | 1,024 |
| Total, serious adverse events | OL Fondaparinux Background + Standard Dose UFH During PCI | 20 | 1,002 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
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 |
| OL Fondaparinux Background + Low Dose UFH During PCI vs OL Fondaparinux Background + Standard Dose UFH During PCI: Number of Participants With Major Bleeding During the Peri-PCI Period | Trial comparisons |
OL Fondaparinux Background + Low Dose UFH During PCI vs OL Fondaparinux Background + Standard Dose UFH During PCI: Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period | Trial comparisons |
| OL Fondaparinux Background + Low Dose UFH During PCI vs OL Fondaparinux Background + Standard Dose UFH During PCI: Number of Participants With Minor Bleeding During the Peri-PCI Period | Trial comparisons |
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 During the Peri-PCI Period, With Death, MI, or TVR at Day 30 | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00790907
GET https://conductscience.org/api/trials/v1/NCT00790907/results?page=2