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The INFUSE - Anterior Myocardial Infarction (AMI) Study

2014-07-23 21:13:21 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Acute Anterior Myocardial Infarction

Intervention

Abciximab local infusion, No local infusion, Thrombus aspiration

Location

Washington Adventist Hospital
Takoma Park
Maryland
United States
20912

Status

Recruiting

Source

Atrium Medical Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:21-0400

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