Trial · NCT01087723
European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial
NCT01087723, Phase 3, Completed, The Medicines Company; results first posted 2016-02-12
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial. Trials, record NCT01087723. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01087723
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial
- NCT number
- NCT01087723
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,198 participants, actual
- Lead sponsor
- The Medicines Company
- Conditions
- Acute Coronary Syndrome
- Interventions
- Bivalirudin, Heparin
- First posted
- 2010-03-16
- Last updated
- 2016-02-12
- Results first posted
- 2016-02-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding | Within 30 days | A participant was defined to have had a composite event if the participant experienced at least 1 of the 2 components (death or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any 1 of the following: intra-cranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in hemoglobin (Hb) concentration of \>4 grams/deciliter (g/dL) without an overt source of bleeding, reduction in hemoglobin concentration of \>3 g/dL with an overt source of bleeding; re-intervention for bleeding, or use of any blood product transfusion. |
| Secondary | The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding | Within 30 days | A participant had a composite event if the participant experienced at least 1 of the 3 components (death, re-infarction \[MI\], or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of \>4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of \>3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. MI was defined as a positive diagnosis of re-infarction (new event) not associated with index PCI. |
| Secondary | The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR) | Within 30 days | Incidence=number of participants to experience the event/total number of at risk participants x 100. Death from any cause at any time. Re-infarction was a positive diagnosis of re-infarction not associated with index PCI. Non-CABG major bleeding was any 1 of: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of \>4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of \>3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. IDR was any refractory ischemia-driven repeat percutaneous intervention or bypass graft surgery involving any native coronary or pre-existing bypass graft vessel. In the absence of pain, new ST segment changes indicative of ischemia, acute pulmonary edema, ventricular arrhythmias, or hemodynamic instability presumed to be ischemic in origin, will constitute sufficient evidence of ischemia. |
| Secondary | The Incidence of Death at 1 Year | Within 1 Year | Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. |
| Secondary | The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO) | Within 30 days | Incidence=the number of participants to experience the event/total number of at risk participants x 100. Major bleeding based on TIMI criteria was defined as any intra-cranial bleeding, or any bleeding associated with clinically overt signs associated with a drop in Hb of \>5 g/dL (or, when Hb was not available, an absolute drop in hematocrit \[Hct\] \>15%). Major bleeding based on GUSTO criteria was defined as severe/life-threatening: intra-cranial hemorrhage or resulting in substantial hemodynamic compromise requiring treatment. |
| Secondary | The Incidence of Minor Bleeding: TIMI and GUSTO | Within 30 days | Incidence=the number of participants to experience the event/total number of at risk participants x 100. Minor bleeding based on TIMI criteria was defined as any clinically overt sign of bleeding (including observation by imaging techniques) that was associated with a fall in Hb of ≥3 g/dL and ≤5 g/dL (or, when Hb was not available, an absolute drop in Hct of ≥9% and ≤15%). Minor bleeding based on GUSTO criteria was defined as other bleed not requiring blood transfusion or causing hemodynamic compromise. |
| Secondary | The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition]) | Within 30 days | Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stent thrombosis, based on the ARC definition, was defined as angiographic confirmation of stent thrombosis, non-occlusive thrombus, occlusive thrombus, or pathological confirmation of stent thrombosis. |
| Secondary | The Incidence of Thrombocytopenia | Within 30 days | Incidence=the number of participants to experience the event/total number of at risk participants x 100. Thrombocytopenia was defined as a post-procedural platelet count \<100,000 cells/millimeter cubed (cells/mm\^3) in a participant with a baseline or pre-procedural platelet count \>100,000 cells/mm\^3. |
| Secondary | The Incidence of Stroke | Within 30 days | Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stroke was defined as a sudden, focal neurological defect resulting from a cerebrovascular cause, resulting in death or lasting greater than 24 hours that was not due to a readily identifiable cause, such as a tumor, infection, or trauma. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding | Within 30 days | Participants who were randomized and signed an ICF; ITT population | percentage of participants | NUMBER |
| SECONDARY | The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding | Within 30 days | Participants who were randomized and signed an ICF; ITT population | percentage of participants | NUMBER |
| SECONDARY | The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR) | Within 30 days | Participants who were randomized and signed an ICF; ITT population | percentage of participants | NUMBER |
| SECONDARY | The Incidence of Death at 1 Year | Within 1 Year | Participants who were randomized and signed an ICF; ITT population | percentage of participants | NUMBER |
| SECONDARY | The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO) | Within 30 days | Participants who were randomized and signed an ICF; ITT population | percentage of participants | NUMBER |
| SECONDARY | The Incidence of Minor Bleeding: TIMI and GUSTO | Within 30 days | Participants who were randomized and signed an ICF; ITT population | percentage of participants | NUMBER |
| SECONDARY | The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition]) | Within 30 days | Participants who were randomized and signed an ICF; ITT population | percentage of participants | NUMBER |
| SECONDARY | The Incidence of Thrombocytopenia | Within 30 days | Participants who were randomized and signed an ICF; ITT population | percentage of participants | NUMBER |
| SECONDARY | The Incidence of Stroke | Within 30 days | Participants who were randomized and signed an ICF; ITT population | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding | Bivalirudin | 5.1 | percentage of participants | ||
| The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding | Standard of Care: Heparins With Optional GPI | 8.5 | percentage of participants | ||
| The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding | Bivalirudin | 6.6 | percentage of participants | ||
| The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding | Standard of Care: Heparins With Optional GPI | 9.2 | percentage of participants | ||
| The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR) | Bivalirudin | Death | 2.9 | percentage of participants | |
| The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR) | Standard of Care: Heparins With Optional GPI | Death | 3.1 | percentage of participants | |
| The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR) | Bivalirudin | Re-infarction | 1.7 | percentage of participants | |
| The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR) | Standard of Care: Heparins With Optional GPI | Re-infarction | 0.9 | percentage of participants | |
| The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR) | Bivalirudin | Non-CABG-related major bleeding | 2.6 | percentage of participants | |
| The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR) | Standard of Care: Heparins With Optional GPI | Non-CABG-related major bleeding | 6.0 | percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bivalirudin | 1,089 | |
| Overall Study | STARTED | Standard of Care: Heparins With Optional GPI | 1,109 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Bivalirudin | 1,099 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Standard of Care: Heparins With Optional GPI | 1,094 | |
| Overall Study | COMPLETED | Bivalirudin | 1,075 | |
| Overall Study | COMPLETED | Standard of Care: Heparins With Optional GPI | 1,089 | |
| Overall Study | NOT COMPLETED | Bivalirudin | 14 | |
| Overall Study | NOT COMPLETED | Standard of Care: Heparins With Optional GPI | 20 |
Source ClinicalTrials.gov
Adverse events204
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 | Ventricular tachycardia | Cardiac disorders | Bivalirudin | 57 | 1,099 | |
| other | Ventricular tachycardia | Cardiac disorders | Standard of Care: Heparins With Optional GPI | 39 | 1,094 | |
| other | Atrial fibrillation | Cardiac disorders | Bivalirudin | 35 | 1,099 | |
| other | Atrial fibrillation | Cardiac disorders | Standard of Care: Heparins With Optional GPI | 35 | 1,094 | |
| other | Bradycardia | Cardiac disorders | Bivalirudin | 20 | 1,099 | |
| other | Bradycardia | Cardiac disorders | Standard of Care: Heparins With Optional GPI | 25 | 1,094 | |
| other | Hypotension | Vascular disorders | Bivalirudin | 22 | 1,099 | |
| other | Hypotension | Vascular disorders | Standard of Care: Heparins With Optional GPI | 20 | 1,094 | |
| serious | Ventricular fibrillation | Cardiac disorders | Bivalirudin | 39 | 1,099 | |
| serious | Ventricular fibrillation | Cardiac disorders | Standard of Care: Heparins With Optional GPI | 28 | 1,094 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bivalirudin | ||
| Total, all-cause mortality | Standard of Care: Heparins With Optional GPI | ||
| Total, other adverse events | Bivalirudin | 134 | 1,099 |
| Total, other adverse events | Standard of Care: Heparins With Optional GPI | 119 | 1,094 |
| Total, serious adverse events | Bivalirudin | 145 | 1,099 |
| Total, serious adverse events | Standard of Care: Heparins With Optional GPI | 129 | 1,094 |
Source ClinicalTrials.gov
Papers9
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Bivalirudin vs Standard of Care: Heparins With Optional GPI: serious adverse events |
Source 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/NCT01087723
GET https://conductscience.org/api/trials/v1/NCT01087723/results?page=2