Safety and Efficacy Study of Eptifibatide in Primary Percutaneous Coronary Intervention (PCI)

University of Ottawa Heart Institute

Status and phase

Completed

Phase 3

Conditions

Myocardial Infarction

Treatments

Drug: Eptifibatide facilitated PCI

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00251823

PO4319

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
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