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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00945308
Recruitment Status : Unknown
Verified July 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 24, 2009
Last Update Posted : July 24, 2009
Information provided by:
Assaf-Harofeh Medical Center

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Eptifibatide Phase 2

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : August 2009
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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.
Active Comparator: Eptifibatide (intravenous) 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

Primary Outcome Measures :
  1. Coronary angiography [ Time Frame: At the time of the procedure ]

Secondary Outcome Measures :
  1. Electrocardiogram [ Time Frame: 90 min after the procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00945308

Contact: Alberto Hendler, MD +972526467757
Contact: Alex Blatt, MD +97257345906

Assaf Harofeh Medical Center Not yet recruiting
Beer Yakov, Israel, 70300
Contact: Alberto Hendler, MD    +9726467757   
Principal Investigator: Alberto Hendler, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center

Responsible Party: Alberto Hendler MD, Assaf harofeh Medical Center Identifier: NCT00945308     History of Changes
Other Study ID Numbers: 97/09
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: July 24, 2009
Last Verified: July 2009

Keywords provided by Assaf-Harofeh Medical Center:
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

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors