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The INFUSE - Anterior Myocardial Infarction (AMI) Study

NCT00976521 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2013-07-08

Study results available
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Summary

This is a multicenter, open-label, controlled, single-blind, randomized study with up to 452 subjects enrolled in up to 50 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 0/1/2 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.

Conditions

  • Acute Anterior Myocardial Infarction

Interventions

DRUG

Abciximab local infusion

Local infusion of abciximab using the ClearWay™ RX Infusion Catheter

OTHER

No local infusion

Intervention without local infusion

PROCEDURE

Thrombus aspiration

Thrombus aspiration

Sponsors & Collaborators

  • Atrium Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Greg W Stone, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-02-29
Completion
2013-04-30

Countries

  • United States
  • Austria
  • Germany
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00976521 on ClinicalTrials.gov