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 |
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
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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