Effectiveness of Intracoronary Injection of Eptifibatide in Primary Coronary Intervention in STEMI Patients (ICE)
|ClinicalTrials.gov Identifier: NCT00945308|
Recruitment Status : Unknown
Verified July 2009 by Assaf-Harofeh Medical Center.
Recruitment status was: Not yet recruiting
First Posted : July 24, 2009
Last Update Posted : July 24, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Drug: Eptifibatide||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||August 2009|
|Estimated Primary Completion Date :||February 2010|
|Estimated Study Completion Date :||February 2010|
|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
- Coronary angiography [ Time Frame: At the time of the procedure ]
- Electrocardiogram [ Time Frame: 90 min after the procedure ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945308
|Contact: Alberto Hendler, MDemail@example.com|
|Contact: Alex Blatt, MDfirstname.lastname@example.org|
|Assaf Harofeh Medical Center||Not yet recruiting|
|Beer Yakov, Israel, 70300|
|Contact: Alberto Hendler, MD +9726467757 email@example.com|
|Principal Investigator: Alberto Hendler, MD|