NCT00719914

Brief Summary

The main purpose of this research study is to try to improve the results of the standard treatment for heart attacks. Normally, heart attack patients get a fast dose and a slow dose of eptifibatide in the emergency room, shortly after arriving. This drug is usually given through a vein in the arm. However, eptifibatide can also be injected directly into the heart's blood supply just before angioplasty, a common procedure to unblock a blood vessel in the heart. This new way of giving the drug is being studying.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

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

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

August 27, 2012

Completed
Last Updated

August 27, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

January 7, 2008

Results QC Date

July 24, 2012

Last Update Submit

July 24, 2012

Conditions

ST-Elevation Myocardial Infarction

Keywords

eptifibatideIntegrilinST-Elevation Myocardial InfarctionAcute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Improvement in Percent Diameter Stenosis of the Culprit Artery Following the IC Bolus Administration of Eptifibatide vs. IC Placebo (Saline) as Assessed With Quantitative Coronary Angiography (QCA)

    30 days

Study Arms (2)

1

ACTIVE COMPARATOR

Intracoronary injection of eptifibatide

Drug: eptifibatide

2

PLACEBO COMPARATOR

Intra-coronary injection of normal saline.

Drug: normal saline

Interventions

eptifibatideDRUG

Intra-coronary injection, weight based, of eptifibatide.

1
normal salineDRUG

Intra-coronary injection, weight based, of normal saline.

2

Eligibility Criteria

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

You may qualify if:

  • Clinical
  • Patients (men or women) at least 18 years of age and
  • Presenting with ischemic chest discomfort \>20 minutes and \<6 hours of duration suggestive of acute myocardial infarction
  • AND:
  • ECG
  • ST elevation \>1mm (\>0.1mV) in two contiguous limb leads OR \>2mm (\>0.2mV) in two contiguous precordial leads

You may not qualify if:

  • CLINICAL
  • Maximal systolic blood pressure \<80 mmHg AFTER initial fluid and/or pressor resuscitation
  • Uncontrolled hypertension (SBP\>180 OR DBP \>110) at time of enrollment
  • Ventricular fibrillation or ventricular tachycardia requiring DC cardioversion
  • Sinus bradycardia (HR \<50/min), third degree or advanced second degree heart block.
  • Known pregnancy
  • New or suspected new left bundle branch block
  • BIOCHEMICAL
  • Known thrombocytopenia (platelet count \<100,000)
  • Known severe renal insufficiency (creatinine \>4.0 mg/dL)
  • INCREASED BLEEDING RISK
  • Active or recent (\<1 year) bleeding or gastrointestinal hemorrhage
  • Major surgery \<1 month
  • Known coagulopathy, platelet disorder or history of thrombocytopenia: If a patient is known to be on chronic warfarin therapy, the International Normalized Ratio (INR) must be known to be \<1.6 in order for the patient to be included
  • Known neoplasm
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cardiology Research Associates

Ormond Beach, Florida, 32174, United States

Location

Crittenton Hospital Medical Center

Rochester, Michigan, 48307, United States

Location

Mid Ohio Heart Clinic

Mansfield, Ohio, 44906, United States

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

EptifibatideSaline Solution

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Peptides, CyclicPeptidesAmino Acids, Peptides, and ProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Limitations and Caveats

Early termination due to poor enrollment.

Results Point of Contact

Title
C. Michael Gibson, MS, MD
Organization
Brigham and Women's Hospital
mgibson@perfuse.org
617-632-7753

Study Officials

  • Eugene Braunwald, M.D.

    The TIMI Study Group

    STUDY CHAIR

  • C. Michael Gibson, M.D.

    The TIMI Study Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2008

First Posted

July 22, 2008

Study Start

November 1, 2007

Primary Completion

November 1, 2008

Study Completion

January 1, 2009

Last Updated

August 27, 2012

Results First Posted

August 27, 2012

Record last verified: 2012-07

Locations

US(3)