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

NCT ID: NCT00945308

Last Updated: 2009-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-02-28

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

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Eptifibatide (intracoronary)

Group Type: ACTIVE_COMPARATOR

Eptifibatide

Intervention Type: DRUG

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.

Eptifibatide (intravenous)

Group Type: ACTIVE_COMPARATOR

Eptifibatide

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assaf harofeh Medical Center

Locations

Assaf Harofeh Medical Center

Beer Yakov, Beer Yakov, Israel

Countries

Israel

Central Contacts

Alberto Hendler, MD

Role: CONTACT

ahendler@asaf.health.gov.il

+972526467757

Alex Blatt, MD

Role: CONTACT

alexb@asaf.health.gov.il

+97257345906

Facility Contacts

Alberto Hendler, MD

Role: primary

ahendler@asaf.health.gov.il

+9726467757

Other Identifiers

97/09

Identifier Type: -

Identifier Source: org_study_id