The INFUSE - Anterior Myocardial Infarction (AMI) Study



Status:Archived
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:September 2009
End Date:May 2012

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A 2x2 Factorial, Randomized, Multicenter, Single-Blind Evaluation of Intracoronary Abciximab Infusion and Aspiration Thrombectomy in Patients Undergoing Percutaneous Coronary Intervention for Anterior ST-Segment Elevation Myocardial Infarction


This is a multicenter, open-label, controlled, single-blind, randomized study with up to 452
subjects enrolled in up to 40 US and European sites. Subjects who present with anterior
ST-elevation myocardial infarction (STEMI) and an occluded proximal or mid left anterior
descending (LAD) with TIMI 0/1 flow will be eligible for randomization to one of the
following arms:

1. Local infusion of abciximab following thrombus aspiration

2. Local infusion of abciximab and no thrombus aspiration

3. No local infusion and thrombus aspiration

4. No local infusion and no thrombus aspiration

In addition, a cardiac magnetic resonance imaging (MRI) sub-study evaluating microvascular
obstruction (MVO) will be performed with up to 160 subjects at up to 20 sites.


The primary objective of the study is to demonstrate that among subjects undergoing primary
PCI for anterior STEMI treated with a bivalirudin monotherapy anticoagulation strategy, the
intracoronary infusion of an abciximab bolus with or without thrombus aspiration prior to
stent implantation, compared to no infusion with or without thrombus aspiration (standard of
care), results in 1) reduced infarct size measured by cardiac MRI at 30 days (range -7
days/+14 days; i.e., between 23 and 44 days), 2) reduce microvascular obstruction (MVO) by
cardiac MRI at 5 + 2 days (i.e., between 3 and 7 days), 3) enhanced ST-segment resolution,
4) improved myocardial perfusion, 5) reduced thrombus burden and angiographic complications,
and 6) no increase in major and minor bleeding.


We found this trial at
8
sites
Virginia Beach, Virginia 23454
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Virginia Beach, VA
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1200 North Elm Street
Greensboro, North Carolina 27401
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Greensboro, NC
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Charlotte, North Carolina 28203
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Charlotte, NC
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Cincinnati, Ohio 45219
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Cincinnati, OH
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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Harrisburg, Pennsylvania 17110
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Harrisburg, PA
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Kingsport, Tennessee 37660
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Kingsport, TN
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Takoma Park, Maryland 20912
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Takoma Park, MD
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