Current partner codePEPTIDESDE
NCT00945308·Phase 2·INTERVENTIONAL

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

Status

Unknown

Phase

Phase 2

Enrollment

50

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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

Interventions

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Jul 24, 2009

  2. Study start

    Aug 2009

  3. Primary completion

    Feb 2010

  4. Study completion

    Feb 2010

  5. Results posted

    Not reported

  6. Registry updated

    Jul 24, 2009

Outcomes

What the study measures.

Primary outcomes

Coronary angiography

Time frame · At the time of the procedure

Secondary outcomes

Electrocardiogram

Time frame · 90 min after the procedure

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
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.

Study locations

1 registered sites.

Israel. Showing up to 24 locations stored in the fast local snapshot.

Assaf Harofeh Medical Center

Beer Yakov, Beer Yakov, Israel

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Eptifibatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.