NCT00976521

The INFUSE - Anterior Myocardial Infarction (AMI) Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 452 (actual)
• Sponsor: Atrium Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Anterior Myocardial Infarction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-02-01
• Completion: 2013-04-01
• First posted: 2009-09-14
• Last updated: 2013-07-08
• Results posted: 2013-07-08

Locations

38 sites across 6 countries: United States, Austria, Germany, Netherlands, Poland, United Kingdom