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

September 3, 2008 updated by: Ottawa Heart Institute Research Corporation

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:

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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)

Secondary Outcome Measures

Outcome Measure
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])

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Collaborators

Schering-Plough
Medtronic

Investigators

  • Principal Investigator: Michel R. Le May, MD, Ottawa Heart Institute Research Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

November 8, 2005

First Submitted That Met QC Criteria

November 8, 2005

First Posted (Estimate)

November 10, 2005

Study Record Updates

Last Update Posted (Estimate)

September 4, 2008

Last Update Submitted That Met QC Criteria

September 3, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO4319

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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