Effectiveness of Intracoronary Injection of Eptifibatide in Primary Coronary Intervention in STEMI Patients (ICE)

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Unknown; Phase 2

Conditions: Acute Myocardial Infarction

Treatments: Drug: Eptifibatide

Study type: Interventional

Funder types: Other

Identifiers

NCT00945308

97/09

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

Eptifibatide (intracoronary)

Active Comparator group

Treatment:

Drug: Eptifibatide

Drug: Eptifibatide

Eptifibatide (intravenous)

Active Comparator group

Treatment:

Drug: Eptifibatide

Drug: Eptifibatide