At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Abciximab local infusion, No local infusion, and 1 other intervention for Acute Anterior Myocardial Infarction. Completed, enrolled 452 participants across 38 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter
Intervention without local infusion
Thrombus aspiration