Clinical trial NCT00945308: Effectiveness of Intracoronary Injection of Eptifibatide in Primary Coronary Intervention in STEMI Patients
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Keywords: Primary PCI
Acute myocardial infarction
Myocardial blush
Primary coronary intervention in acute myocardial infarction
focusing on the effect of the study drug on the immediate TIMI
flow at the infarct related artery and on the myocardial
perfusion evaluated by the TIMI myocardial perfusion grade or
blush
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Coronary angiography
timeFrame: At the time of the procedure
Secondary outcomes:
measure: Electrocardiogram
timeFrame: 90 min after the procedure
Other outcomes:
Locations:
city: Beer Yakov
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
References: