Trial · NCT01522417
Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention
NCT01522417, Phase 2, Completed, Medicure; results first posted 2021-04-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention. Trials, record NCT01522417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01522417
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention
- NCT number
- NCT01522417
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 535 participants, actual
- Lead sponsor
- Medicure
- Conditions
- Myocardial Infarction, Acute Coronary Syndromes, Unstable Angina
- Interventions
- Short Tirofiban, Eptifibatide, Long Tirofiban
- First posted
- 2012-01-31
- Last updated
- 2021-05-13
- Results first posted
- 2021-04-20
- Limitations and caveats
- Randomization into the long tirofiban arm was initiated after 159 patients were already enrolled into either the short tirofiban or long eptifibatide arms.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding | 48 hours or hospital discharge, whichever came first | The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria. |
| Secondary | The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization | 48 hours or hospital discharge, whichever came first | The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), or urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) |
| Secondary | Individual Components of Death, Urgent Target Revascularization or Major Bleeding | 48 hours or hospital discharge, whichever came first | Individual components of death (any-cause), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 major bleeding criteria. |
| Secondary | Individual Components of Periprocedural Myonecrosis | 48 hours or hospital discharge, whichever came first | Individual components of periprocedural myonecrosis (PPM) (defined as ≥ 3 times, ≥ 10 times, ≥ 20 times or ≥ 50 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value) |
| Secondary | The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM) (≥ 10x Troponin), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding | 48 hours or hospital discharge, whichever came first | The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 10 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding | 48 hours or hospital discharge, whichever came first | As per the protocol, a patient must have a pre-PCI troponin measurement and at least one troponin measurement within 48 hours following PCI or hospital discharge, whichever comes first, otherwise they were excluded from the primary composite endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization | 48 hours or hospital discharge, whichever came first | As per the protocol, a patient must have a pre-PCI troponin measurement and at least one troponin measurement within 48 hours following PCI or hospital discharge, whichever comes first, otherwise they were excluded from the primary composite endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Individual Components of Death, Urgent Target Revascularization or Major Bleeding | 48 hours or hospital discharge, whichever came first | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Individual Components of Periprocedural Myonecrosis | 48 hours or hospital discharge, whichever came first | As per the protocol, a patient must have a pre-PCI troponin measurement and at least one troponin measurement within 48 hours following PCI or hospital discharge, whichever comes first, otherwise they were excluded from the individual PPM endpoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM) (≥ 10x Troponin), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding | 48 hours or hospital discharge, whichever came first | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding | Short Tirofiban (Aggrastat) | 69 | Participants | ||
| The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding | Eptifibatide (Integrilin) | 60 | Participants | ||
| The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding | Long Tirofiban (Aggrastat) | 48 | Participants | ||
| The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization | Short Tirofiban (Aggrastat) | 69 | Participants | ||
| The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization | Eptifibatide (Integrilin) | 60 | Participants | ||
| The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization | Long Tirofiban (Aggrastat) | 45 | Participants | ||
| Individual Components of Death, Urgent Target Revascularization or Major Bleeding | Short Tirofiban (Aggrastat) | Death | 0 | Participants | |
| Individual Components of Death, Urgent Target Revascularization or Major Bleeding | Eptifibatide (Integrilin) | Death | 1 | Participants | |
| Individual Components of Death, Urgent Target Revascularization or Major Bleeding | Long Tirofiban (Aggrastat) | Death | 0 | Participants | |
| Individual Components of Death, Urgent Target Revascularization or Major Bleeding | Short Tirofiban (Aggrastat) | uTVR | 1 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Short Tirofiban (Aggrastat) | 209 | |
| Overall Study | STARTED | Eptifibatide (Integrilin) | 202 | |
| Overall Study | STARTED | Long Tirofiban (Aggrastat) | 124 | |
| Overall Study | COMPLETED | Short Tirofiban (Aggrastat) | 209 | |
| Overall Study | COMPLETED | Eptifibatide (Integrilin) | 202 | |
| Overall Study | COMPLETED | Long Tirofiban (Aggrastat) | 124 | |
| Overall Study | NOT COMPLETED | Short Tirofiban (Aggrastat) | 0 | |
| Overall Study | NOT COMPLETED | Eptifibatide (Integrilin) | 0 | |
| Overall Study | NOT COMPLETED | Long Tirofiban (Aggrastat) | 0 |
Source ClinicalTrials.gov
Adverse events294
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 | Catheter Site Haematoma | General disorders | Short Tirofiban (Aggrastat) | 7 | 209 | 7 |
| other | Catheter Site Haematoma | General disorders | Eptifibatide (Integrilin) | 8 | 202 | 8 |
| other | Catheter Site Haematoma | General disorders | Long Tirofiban (Aggrastat) | 4 | 124 | 4 |
| other | Application Site Haemorrhage | General disorders | Short Tirofiban (Aggrastat) | 1 | 209 | 1 |
| other | Application Site Haemorrhage | General disorders | Eptifibatide (Integrilin) | 5 | 202 | 5 |
| other | Application Site Haemorrhage | General disorders | Long Tirofiban (Aggrastat) | 2 | 124 | 2 |
| other | Infusion Site Haematoma | General disorders | Short Tirofiban (Aggrastat) | 1 | 209 | 1 |
| other | Infusion Site Haematoma | General disorders | Eptifibatide (Integrilin) | 0 | 202 | 0 |
| other | Infusion Site Haematoma | General disorders | Long Tirofiban (Aggrastat) | 0 | 124 | 0 |
| other | Non-Cardiac Chest Pain | General disorders | Short Tirofiban (Aggrastat) | 0 | 209 | 0 |
1 to 10 of 294Source ClinicalTrials.gov
See all 294 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Short Tirofiban (Aggrastat) | 0 | 209 |
| Total, all-cause mortality | Eptifibatide (Integrilin) | 1 | 202 |
| Total, all-cause mortality | Long Tirofiban (Aggrastat) | 0 | 124 |
| Total, other adverse events | Short Tirofiban (Aggrastat) | 45 | 209 |
| Total, other adverse events | Eptifibatide (Integrilin) | 55 | 202 |
| Total, other adverse events | Long Tirofiban (Aggrastat) | 50 | 124 |
| Total, serious adverse events | Short Tirofiban (Aggrastat) | 8 | 209 |
| Total, serious adverse events | Eptifibatide (Integrilin) | 11 | 202 |
| Total, serious adverse events | Long Tirofiban (Aggrastat) | 7 | 124 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01522417
GET https://conductscience.org/api/trials/v1/NCT01522417/results?page=2