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

Effectiveness of Intracoronary Injection of Eptifibatide as Adjunctive Antiplatelet Therapy in Primary Coronary Intervention in Patients With ST Segment Elevation Acute Myocardial Infarction.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00945308

Acronym

ICE

Enrollment

Registered

2009-07-24

Start date

2009-08-31

Completion date

2010-02-28

Last updated

2009-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Interventions

DRUGEptifibatide

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Coronary angiography	At the time of the procedure

Secondary

Measure	Time frame
Electrocardiogram	90 min after the procedure

Countries

Israel

Contacts

Primary ContactAlberto Hendler, MD

ahendler@asaf.health.gov.il+972526467757

Backup ContactAlex Blatt, MD

alexb@asaf.health.gov.il+97257345906

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026