Effectiveness of Intracoronary Injection of Eptifibatide in Primary Coronary Intervention in STEMI Patients

Study Overview
=================
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

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.

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Eptifibatide
* Drug: Eptifibatide


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Eptifibatide (intracoronary)<br> | Drug: Eptifibatide<br>* 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.<br>|
| Active Comparator: Eptifibatide (intravenous)<br> | Drug: Eptifibatide<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary angiography |  | At the time of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrocardiogram |  | 90 min after the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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