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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Drug: Eptifibatide; Drug: Eptifibatide

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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alberto Hendler, MD; Phone Number: +972526467757; Email: ahendler@asaf.health.gov.il
• Study Contact Backup: Name: Alex Blatt, MD; Phone Number: +97257345906; Email: alexb@asaf.health.gov.il

Study Locations

• Israel
  • Beer Yakov, Israel, 70300
    • Assaf Harofeh Medical Center
    • Contact: Alberto Hendler, MD; Phone Number: +9726467757; Email: ahendler@asaf.health.gov.il
    • Principal Investigator: Alberto Hendler, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Eptifibatide (intracoronary)	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.; Drug: Eptifibatide; 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
Active Comparator: Eptifibatide (intravenous)	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.; Drug: Eptifibatide; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Coronary angiography	At the time of the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Electrocardiogram	90 min after the procedure

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Anticipated): February 1, 2010
• Study Completion (Anticipated): February 1, 2010

Study Registration Dates

• First Submitted: July 8, 2009
• First Submitted That Met QC Criteria: July 23, 2009
• First Posted (Estimate): July 24, 2009

Study Record Updates

• Last Update Posted (Estimate): July 24, 2009
• Last Update Submitted That Met QC Criteria: July 23, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Platelet Aggregation Inhibitors; Eptifibatide
• Other Study ID Numbers: 97/09