Myocardial InfarctionPhase 3NCT00251823
Safety and Efficacy Study of Eptifibatide in Primary Percutaneous Coronary Intervention (PCI)
A Phase 3 study testing Eptifibatide facilitated PCI in people with Myocardial Infarction, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
Rationale: ST-elevation myocardial infarction (STEMI) is usually triggered by rupture of an atherosclerotic plaque that then accumulates platelets and fibrin and leads to an occlusive coronary thrombus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Eptifibatide facilitated PCI
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2005to Sep 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ischemic chest discomfort of 30 minutes duration
- Onset of chest pain 12 hours prior to entry into the study
- ST segment elevation of > 1 mm (0.1 mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead electrocardiogram [ECG]), or left bundle branch block not known to be old
Who cannot join
- Active bleeding
- History of stroke within 90 days or any intracranial bleed.
- Major surgery or trauma within the past 6 weeks
- Uncontrolled hypertension (systolic blood pressure [SBP] 200 mm Hg and/or diastolic blood pressure [DBP] 110 mm Hg despite treatment)
- Prolonged (> 10 minutes) cardiopulmonary resuscitation
- Inadequate vascular access
Show all 19Show fewer
- PCI within the last 30 days
- Thrombolytic agents within the preceding 7 days
- Concurrent use of warfarin
- A blood coagulation disorder (i.e. international normalized ratio [INR] > 2.0, platelet count < 100,000/mm3, or hematocrit < 30%)
- Intolerance to aspirin or clopidogrel
- A subcutaneous therapeutic dose of any low molecular weight heparin (LMWH) within 12 hours
- Known severe contrast allergy
- Other medical condition that is likely to result in death within 12 months
- Participation in a study or another investigational device or drug trial within the past four weeks
- Pregnancy
- Known severe renal impairment (creatinine > 200 mole/l)
- Sustained hypotension, systolic blood pressure < 80 mm Hg, or the need for intravenous (IV) inotropes and/or intraaortic balloon counterpulsation to support the blood pressure
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of Eptifibatide-Facilitated Percutaneous Coronary Angioplasty Versus Primary Percutaneous Coronary Angioplasty Alone
Rationale:
ST-elevation myocardial infarction (STEMI) is usually triggered by rupture of an atherosclerotic plaque that then accumulates platelets and fibrin and leads to an occlusive coronary thrombus. Clinical benefits obtained with revascularization of the infarct related artery (IRA) depend on the achievement of four goals:
Read more
- Early reperfusion
- Full restoration of normal flow in the epicardial vessels
- Full restoration of flow in the microcirculation, and
- Preservation of myocardial function.
Reperfusion of the IRA can be achieved pharmacologically with intravenous thrombolytic agents, or mechanically with percutaneous coronary intervention (PCI). In Canada, thrombolysis is the current standard of care in most hospitals, although there is mounting evidence that primary PCI is superior, and many Canadian centres are shifting towards this strategy. To offer primary PCI to community hospitals without on site cardiac catheterization facilities, regional programs need to be present that allow rapid transfer to invasive centers that offer this procedure round-the-clock.
Recent evidence suggests that angiographic and clinical results with primary PCI could be further enhanced by facilitation with a pharmacological treatment given prior to the procedure. The present proposal plans to examine the safety and efficacy of eptifibatide to facilitate coronary angioplasty in STEMI in patients who present to centres with and without on-site catheterization facilities.
The primary outcome measure will be a composite clinical endpoint including death, recurrent myocardial infarction, recurrent unstable ischemia, or stroke, at 30 days.
Secondary endpoints include the percent thrombolysis in myocardial infarction (TIMI) grade 3 coronary flow after the PCI, myocardial perfusion score, individual clinical outcomes as listed for the primary endpoint, resolution of ST-segment elevation, requirement for subsequent revascularization, frequency of congestive heart failure (CHF), cardiogenic shock, and Canadian Cardiovascular Society (CCS) angina class.
- Conditions
- Myocardial Infarction
- Being tested
- Eptifibatide facilitated PCI
- Keywords
- ST-Elevation Myocardial Infarction
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eptifibatide facilitated PCIDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary clinical endpoint is a composite measure of clinical outcomes of death, recurrent myocardial infarction, and recurrent severe ischemia, which will be assessed at 30 days after the index acute myocardial infarction (AMI)
Secondary outcomes (6)
Determine if a facilitated PCI strategy with early initiation of eptifibatide improves the percentage of patients with TIMI grade 3 flow measured at the time of baseline angiography
improves post procedural TIMI perfusion scoreC
improves ST-segment elevation resolution, a surrogate marker of clinical efficacy
improves left ventricular (LV) ejection fraction
improves functional capacity
decreases subsequent revascularization (PCI , or coronary artery bypass graft [CABG])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startJul 2005
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough, Medtronic
- Investigators
- Michel R. Le May, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251823
- Sponsor's protocol ID
- PO4319
- Status last verified
- Sep 2008
- First submitted
- 8 Nov 2005
- Last updated
- 4 Sep 2008
- Results posted
- No
Publications
Zeymer U, Zahn R, Schiele R, Jansen W, Girth E, Gitt A, Seidl K, Schroder R, Schneider S, Senges J. Early eptifibatide improves TIMI 3 patency before primary percutaneous coronary intervention for acute ST elevation myocardial infarction: results of the randomized integrilin in acute myocardial infarction (INTAMI) pilot trial. Eur Heart J. 2005 Oct;26(19):1971-7. doi: 10.1093/eurheartj/ehi293. Epub 2005 Apr 27.
PubMed 15857851
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Eptifibatide-Facilitated Percutaneous Coronary Angioplasty Versus Primary Percutaneous Coronary Angioplasty Alone
- ClinicalTrials.gov ID
- NCT00251823
- Acronym / sponsor ID
- PO4319
- Conditions
- Myocardial Infarction
- Keywords
- ST-Elevation Myocardial Infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Schering-Plough, Medtronic
- Study start
- Jul 2005
- Study completion
- Sep 2008 (actual)
- First posted
- 10 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale:
ST-elevation myocardial infarction (STEMI) is usually triggered by rupture of an atherosclerotic plaque that then accumulates platelets and fibrin and leads to an occlusive coronary thrombus. Clinical benefits obtained with revascularization of the infarct related artery (IRA) depend on the achievement of four goals:
- Early reperfusion
- Full restoration of normal flow in the epicardial vessels
- Full restoration of flow in the microcirculation, and
- Preservation of myocardial function.
Reperfusion of the IRA can be achieved pharmacologically with intravenous thrombolytic agents, or mechanically with percutaneous coronary intervention (PCI). In Canada, thrombolysis is the current standard of care in most hospitals, although there is mounting evidence that primary PCI is superior, and many Canadian centres are shifting towards this strategy. To offer primary PCI to community hospitals without on site cardiac catheterization facilities, regional programs need to be present that allow rapid transfer to invasive centers that offer this procedure round-the-clock.
Recent evidence suggests that angiographic and clinical results with primary PCI could be further enhanced by facilitation with a pharmacological treatment given prior to the procedure. The present proposal plans to examine the safety and efficacy of eptifibatide to facilitate coronary angioplasty in STEMI in patients who present to centres with and without on-site catheterization facilities.
The primary outcome measure will be a composite clinical endpoint including death, recurrent myocardial infarction, recurrent unstable ischemia, or stroke, at 30 days.
Secondary endpoints include the percent thrombolysis in myocardial infarction (TIMI) grade 3 coronary flow after the PCI, myocardial perfusion score, individual clinical outcomes as listed for the primary endpoint, resolution of ST-segment elevation, requirement for subsequent revascularization, frequency of congestive heart failure (CHF), cardiogenic shock, and Canadian Cardiovascular Society (CCS) angina class.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Ischemic chest discomfort of 30 minutes duration
- Onset of chest pain 12 hours prior to entry into the study
- ST segment elevation of > 1 mm (0.1 mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead electrocardiogram [ECG]), or left bundle branch block not known to be old
Key exclusion criteria (19 listed)
- Active bleeding
- History of stroke within 90 days or any intracranial bleed.
- Major surgery or trauma within the past 6 weeks
- Uncontrolled hypertension (systolic blood pressure [SBP] 200 mm Hg and/or diastolic blood pressure [DBP] 110 mm Hg despite treatment)
- Prolonged (> 10 minutes) cardiopulmonary resuscitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eptifibatide facilitated PCI | Drug | – |
Primary outcome
The primary clinical endpoint is a composite measure of clinical outcomes of death, recurrent myocardial infarction, and recurrent severe ischemia, which will be assessed at 30 days after the index acute myocardial infarction (AMI)
6 secondary outcomes
Determine if a facilitated PCI strategy with early initiation of eptifibatide improves the percentage of patients with TIMI grade 3 flow measured at the time of baseline angiography
improves post procedural TIMI perfusion scoreC
improves ST-segment elevation resolution, a surrogate marker of clinical efficacy
improves left ventricular (LV) ejection fraction
improves functional capacity
decreases subsequent revascularization (PCI , or coronary artery bypass graft [CABG])
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2008.
- Background: PubMed 15857851Zeymer U, Zahn R, Schiele R, Jansen W, Girth E, Gitt A, Seidl K, Schroder R, Schneider S, Senges J. Early eptifibatide improves TIMI 3 patency before primary percutaneous coronary intervention for acute ST elevation myocardial infarction: results of the randomized integrilin in acute myocardial infarction (INTAMI) pilot trial. Eur Heart J. 2005 Oct;26(19):1971-7. doi: 10.1093/eurheartj/ehi293. Epub 2005 Apr 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel R. Le May, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eptifibatide facilitated PCI in people with Myocardial Infarction, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary clinical endpoint is a composite measure of clinical outcomes of death, recurrent myocardial infarction, and recurrent severe ischemia, which will be assessed at 30 days after the index acute myocardial infarction (AMI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00251823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2008.