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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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Medical and Biotech [MESH] Definitions

Use of any infusion therapy on an ambulatory, outpatient, or other non-institutionalized basis.

Fluid propulsion systems driven mechanically, electrically, or osmotically that are used to inject (or infuse) over time agents into a patient or experimental animal; used routinely in hospitals to maintain a patent intravenous line, to administer antineoplastic agents and other drugs in thromboembolism, heart disease, diabetes mellitus (INSULIN INFUSION SYSTEMS is also available), and other disorders.

Portable or implantable devices for infusion of insulin. Includes open-loop systems which may be patient-operated or controlled by a pre-set program and are designed for constant delivery of small quantities of insulin, increased during food ingestion, and closed-loop systems which deliver quantities of insulin automatically based on an electronic glucose sensor.

Formation of an infarct, which is NECROSIS in tissue due to local ISCHEMIA resulting from obstruction of BLOOD CIRCULATION, most commonly by a THROMBUS or EMBOLUS.

Adverse reactions that occur initially at the site of injection or infusion. Milder type is confined to a local allergic flare reaction. A more severe reaction is caused by extravasation of VESICANTS from the blood vessel at the site of injection and can cause damage to the surrounding tissue. In tumor flare reaction symptoms involve well beyond the injection site such as an increase in the tumor size and tumor markers levels, bone pain, and HYPERCALCEMIA.

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