Effectiveness of Intracoronary Injection of Eptifibatide in Primary Coronary Intervention in STEMI Patients (ICE)
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Effectiveness of Intracoronary Injection of Eptifibatide as Adjunctive Antiplatelet Therapy in Primary Coronary Intervention in Patients With ST Segment Elevation Acute Myocardial Infarction.|
- Coronary angiography [ Time Frame: At the time of the procedure ] [ Designated as safety issue: No ]
- Electrocardiogram [ Time Frame: 90 min after the procedure ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||February 2010|
|Estimated Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: Eptifibatide (intracoronary)||
Intracoronary injection of Eptifibatide injected in two consecutive bolus of 180 mcg/kg each, followed immediately by continuous infusion of 2 mcg/kg/min for 12 hs.
|Active Comparator: Eptifibatide (intravenous)||
Intravenous injection of Eptifibatide in two consecutive boluses of 180 mcg/kg followed by continuous intravenous injection dosing 2 mcg/kg/min for 12 hours
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
|Contact: Alberto Hendler, MDfirstname.lastname@example.org|
|Contact: Alex Blatt, MDemail@example.com|
|Assaf Harofeh Medical Center||Not yet recruiting|
|Beer Yakov, Israel, 70300|
|Contact: Alberto Hendler, MD +9726467757 firstname.lastname@example.org|
|Principal Investigator: Alberto Hendler, MD|