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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00945308
First received: July 8, 2009
Last updated: July 23, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Acute Myocardial Infarction
Drug: Eptifibatide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Coronary angiography [ Time Frame: At the time of the procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Electrocardiogram [ Time Frame: 90 min after the procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945308

Contacts
Contact: Alberto Hendler, MD +972526467757 ahendler@asaf.health.gov.il
Contact: Alex Blatt, MD +97257345906 alexb@asaf.health.gov.il

Locations
Israel
Assaf Harofeh Medical Center Not yet recruiting
Beer Yakov, Israel, 70300
Contact: Alberto Hendler, MD    +9726467757    ahendler@asaf.health.gov.il   
Principal Investigator: Alberto Hendler, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

No publications provided

Responsible Party: Alberto Hendler MD, Assaf harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00945308     History of Changes
Other Study ID Numbers: 97/09
Study First Received: July 8, 2009
Last Updated: July 23, 2009
Health Authority: Israel: Ministry of Health

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
blush

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Eptifibatide
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014