NCT00945308

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2009

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

July 24, 2009

Status Verified

July 1, 2009

Enrollment Period

6 months

First QC Date

July 8, 2009

Last Update Submit

July 23, 2009

Conditions

Acute Myocardial Infarction

Keywords

Primary PCIAcute myocardial infarctionMyocardial blushPrimary coronary intervention in acute myocardial infarctionfocusing on the effect of the study drug on the immediate TIMIflow at the infarct related artery and on the myocardialperfusion evaluated by the TIMI myocardial perfusion grade orblush

Outcome Measures

Primary Outcomes (1)

  • Coronary angiography

    At the time of the procedure

Secondary Outcomes (1)

  • Electrocardiogram

    90 min after the procedure

Study Arms (2)

Eptifibatide (intracoronary)

ACTIVE COMPARATOR
Drug: Eptifibatide

Eptifibatide (intravenous)

ACTIVE COMPARATOR
Drug: Eptifibatide

Interventions

EptifibatideDRUG

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 (intracoronary)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofeh Medical Center

Beer Yakov, Beer Yakov, 70300, Israel

Location

MeSH Terms

Conditions

Blushing

Interventions

Eptifibatide

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehavior

Intervention Hierarchy (Ancestors)

Peptides, CyclicPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Alberto Hendler, MD

CONTACT

+972526467757ahendler@asaf.health.gov.il

Alex Blatt, MD

CONTACT

+97257345906alexb@asaf.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 8, 2009

First Posted

July 24, 2009

Study Start

August 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

July 24, 2009

Record last verified: 2009-07

Locations

IL(1)