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

This study has been completed.
Sponsor:
Collaborators:
Schering-Plough
Medtronic
Information provided by:
University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT00251823
First received: November 8, 2005
Last updated: September 3, 2008
Last verified: September 2008
  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:

  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.


Condition Intervention Phase
Myocardial Infarction
Drug: Eptifibatide facilitated PCI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Eptifibatide-Facilitated Percutaneous Coronary Angioplasty Versus Primary Percutaneous Coronary Angioplasty Alone

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Michel R. Le May, MD University of Ottawa Heart Institute
  More Information

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

Keywords provided by University of Ottawa Heart Institute:
ST-Elevation Myocardial Infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Eptifibatide
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014