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

Primary Purpose

Acute Myocardial Infarction

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Eptifibatide
Eptifibatide
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Assaf Harofeh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Eptifibatide (intracoronary)

Eptifibatide (intravenous)

Arm Description

Outcomes

Primary Outcome Measures

Coronary angiography

Secondary Outcome Measures

Electrocardiogram

Full Information

First Posted
July 8, 2009
Last Updated
July 23, 2009
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00945308
Brief Title
Effectiveness of Intracoronary Injection of Eptifibatide in Primary Coronary Intervention in STEMI Patients
Acronym
ICE
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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
February 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eptifibatide (intracoronary)
Arm Type
Active Comparator
Arm Title
Eptifibatide (intravenous)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Eptifibatide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Eptifibatide
Intervention Description
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 Measure Information:
Title
Coronary angiography
Time Frame
At the time of the procedure
Secondary Outcome Measure Information:
Title
Electrocardiogram
Time Frame
90 min after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto Hendler, MD
Phone
+972526467757
Email
ahendler@asaf.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Blatt, MD
Phone
+97257345906
Email
alexb@asaf.health.gov.il
Facility Information:
Facility Name
Assaf Harofeh Medical Center
City
Beer Yakov
ZIP/Postal Code
70300
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Hendler, MD
Phone
+9726467757
Email
ahendler@asaf.health.gov.il
First Name & Middle Initial & Last Name & Degree
Alberto Hendler, MD

12. IPD Sharing Statement

Learn more about this trial

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

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