Safety and Efficacy Study of Eptifibatide in Primary Percutaneous Coronary Intervention (PCI)
Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
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. Clinical benefits obtained with revascularization of the infarct related
artery (IRA) depend on the achievement of four goals:
1. Early reperfusion
2. Full restoration of normal flow in the epicardial vessels
3. Full restoration of flow in the microcirculation, and
4. 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.