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Clinical Trial Summary

The achievement of high local concentration of Eptifibatide, a GP 2b3a inhibitor,via direct intracoronary injection, promotes (in vitro) clot disaggregation. It remains unclear if it is of superior benefit than the routine intravenous administration of these agents.

In patients presenting with acute myocardial infarction, and undergoing primary coronary intervention, intracoronary administration of Eptifibatide may increase local drug concentration by several orders of magnitude and promote clot disaggregation with a minimal increase in systemic drug concentration, and in that way enhancing myocardial perfusion and survival.


Clinical Trial Description

Patients will be randomized, prospectively, single blinded into one of two arms:1)intravenous administration of Eptifibatide and 2) intracoronary administration. The primary end-point will be the angiographic achievement of TIMI 3 flow at the infarct related artery and TIMI myocardial perfusion grade (blush) and the electrocardiographic surrogate of myocardial perfusion the ST segment resolution.

The secondary end-points will be the occurrence of bleeding or hemorrhagic complication according to TIMI classification and the LVEF at one month compared with baseline ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00945308
Study type Interventional
Source Assaf-Harofeh Medical Center
Contact Alberto Hendler, MD
Phone +972526467757
Email ahendler@asaf.health.gov.il
Status Not yet recruiting
Phase Phase 2
Start date August 2009
Completion date February 2010

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