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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00251823
Recruitment Status : Completed
First Posted : November 10, 2005
Last Update Posted : September 4, 2008
Sponsor:
Collaborators:
Schering-Plough
Medtronic
Information provided by:
Ottawa Heart Institute Research Corporation

Tracking Information
First Submitted Date  ICMJE November 8, 2005
First Posted Date  ICMJE November 10, 2005
Last Update Posted Date September 4, 2008
Study Start Date  ICMJE July 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2006)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 8, 2005)
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 AMI
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2006)
  • 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])
Original Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2005)
  • Determine if a facilitated PCI strategy with early initiation of eptifibatide
  • 1. improves the percentage of patients with TIMI grade 3 flow measured at the time of baseline angiography
  • 2. improves post procedural TIMI perfusion scoreC
  • 3. improves ST-segment elevation resolution, a surrogate marker of clinical efficacy
  • 4. improves LV ejection fraction
  • 5. improves functional capacity
  • 6. decreases subsequent revascularization (PCI , or CABG)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Eptifibatide in Primary Percutaneous Coronary Intervention (PCI)
Official Title  ICMJE The Safety and Efficacy of Eptifibatide-Facilitated Percutaneous Coronary Angioplasty Versus Primary Percutaneous Coronary Angioplasty Alone
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE Drug: Eptifibatide facilitated PCI
Study Arms  ICMJE Not Provided
Publications * Zeymer U, Zahn R, Schiele R, Jansen W, Girth E, Gitt A, Seidl K, Schröder 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 8, 2005)
400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00251823
Other Study ID Numbers  ICMJE PO4319
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Ottawa Heart Institute Research Corporation
Collaborators  ICMJE
  • Schering-Plough
  • Medtronic
Investigators  ICMJE
Principal Investigator: Michel R. Le May, MD Ottawa Heart Institute Research Corporation
PRS Account Ottawa Heart Institute Research Corporation
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP