Safety and Efficacy Study of Eptifibatide in Primary Percutaneous Coronary Intervention (PCI) - Full Text View

Sponsors and Collaborators:	University of Ottawa Heart Institute Schering-Plough Medtronic Of Canada Ltd.
Information provided by:	University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:	NCT00251823

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction	Drug: Eptifibatide facilitated PCI	Phase III

MedlinePlus related topics: Angioplasty Heart Attack

Drug Information available for: Eptifibatide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Safety and Efficacy of Eptifibatide-Facilitated Percutaneous Coronary Angioplasty Versus Primary Percutaneous Coronary Angioplasty Alone

Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:

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 Outcome Measures:

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])

Estimated Enrollment:	400
Study Start Date:	July 2005
Study Completion Date:	September 2008

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251823

Locations

Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7

Sponsors and Collaborators

University of Ottawa Heart Institute

Schering-Plough

Medtronic Of Canada Ltd.

Investigators

Principal Investigator:

Michel R. Le May, MD

University of Ottawa Heart Institute

More Information

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. Epub 2005 Apr 27.

Study ID Numbers:	PO4319
Study First Received:	November 8, 2005
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00251823
Health Authority:	Canada: Health Canada

Keywords provided by University of Ottawa Heart Institute:

ST-Elevation Myocardial Infarction

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Eptifibatide
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Therapeutic Uses
Hematologic Agents

Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009