NCT00251823

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. 1.Early reperfusion
  2. 2.Full restoration of normal flow in the epicardial vessels
  3. 3.Full restoration of flow in the microcirculation, and
  4. 4.Preservation of myocardial function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2005

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 4, 2008

Status Verified

September 1, 2008

First QC Date

November 8, 2005

Last Update Submit

September 3, 2008

Conditions

Myocardial Infarction

Keywords

ST-Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

Eptifibatide facilitated PCIDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (1)

  • 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. doi: 10.1093/eurheartj/ehi293. Epub 2005 Apr 27.

    PMID: 15857851BACKGROUND

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Michel R. Le May, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2005

First Posted

November 10, 2005

Study Start

July 1, 2005

Study Completion

September 1, 2008

Last Updated

September 4, 2008

Record last verified: 2008-09

Locations

CA(1)