DRUG
Eptifibatide
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.
Status
Unknown
Phase
Phase 2
Enrollment
50
Locations
1
Results
Not posted
Publications
0
Study 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.
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
Interventions
DRUG
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.
DRUG
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
Timeline
First posted
Jul 24, 2009
Study start
Aug 2009
Primary completion
Feb 2010
Study completion
Feb 2010
Results posted
Not reported
Registry updated
Jul 24, 2009
Outcomes
Coronary angiography
Time frame · At the time of the procedure
Electrocardiogram
Time frame · 90 min after the procedure
Eligibility
Inclusion Criteria: * Acute myocardial infarction candidate for primary coronary angioplasty, presenting within 12 hours of onset of pain and ability to clearly identified only one infarct related artery. Exclusion Criteria: * Contraindications for antiplatelet therapy such as bleeding disorders, * Thrombocytopenia, * Severe uncontrolled hypertension, * Recent stroke (\<6 months), * Intracranial hemorrhage at any time * Patients after recent major surgery (\<30 days), * Previous myocardial infarction * Previous revascularization either by CABG or PCI and 9)patients presented with cardiogenic shock.
Study locations
Israel. Showing up to 24 locations stored in the fast local snapshot.
Assaf Harofeh Medical Center
Beer Yakov, Beer Yakov, Israel
Publications
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.