INFUSE AMI

• Research type

  Research Study

• Full title

  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

• IRAS ID

  25447

• Contact name

  Anthony Gershlick

• Sponsor organisation

  Atrium Medical Corporation

• Eudract number

  2009-013425-42

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The Infuse MI trial is a multicenter, open-label, controlled, single-blind, randomized study of up to 452 subjects presenting with anterior ST Elevation Myocardial Infarction (Heart Attack). Patients will be admitted to hospital for a Primary Percutaneous Coronary Intervention (emergency treatment of their heart attack) and if eligible, could be randomized to one of the following arms: 1. Local infusion of abciximab and 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 Abciximab is a platelet aggregation inhibitor that prevents platelets from sticking together & causing a clot to form in the coronary artery. In this study it will be given directly into the coronary artery using a Clearway?½ Infusion Catheter. If randomized to receive Thrombus Aspiration, the clot will be removed using an Export© Aspiration Catheter which is a system with syringe for manual (thrombus) aspiration and has a CE mark. The primary objective of the study is to demonstrate that among subjects undergoing primary PCI for anterior STEMI, 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 i.e., between 23 and 44, 2) reduce microvascular obstruction (MVO) by cardiac MRI at 5 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. Subjects will be followed clinically in-hospital, at 30 days and at 12 months following the index procedure. In conclusion, the Infuse AMI trial will study and serve to establish whether local intra-coronary abciximab and whether adjunctive thrombus aspiration provides added benefit over and beyond the current standard of care that has been established in the HORIZONS trial for STEMI patients which represents the control arm (arm 4) of the Infuse protocol.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  09/H0907/68

• Date of REC Opinion

  20 Nov 2009

• REC opinion

  Further Information Favourable Opinion