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A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks

NCT ID: NCT00719914

Last Updated: 2012-08-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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The primary objective of the IC-TITAN study is to demonstrate that an IC bolus of eptifibatide added to an upstream double-bolus and infusion regimen of eptifibatide administered intravenously and initiated early in the ER will result in significant additional clot resolution in vivo when compared with an IC injection of placebo (saline). The primary endpoint chosen to evaluate this hypothesis is the 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).

Conditions

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ST-Elevation Myocardial Infarction

Keywords

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eptifibatide Integrilin ST-Elevation Myocardial Infarction Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Intracoronary injection of eptifibatide

Group Type ACTIVE_COMPARATOR

eptifibatide

Intervention Type DRUG

Intra-coronary injection, weight based, of eptifibatide.

eptifibatide

Intervention Type DRUG

Intra-coronary injection, based on weight, of eptifibatide

2

Intra-coronary injection of normal saline.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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

Interventions

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eptifibatide

Intra-coronary injection, weight based, of eptifibatide.

Intervention Type DRUG

eptifibatide

Intra-coronary injection, based on weight, of eptifibatide

Intervention Type DRUG

normal saline

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
* Any history of hemorrhagic cerebrovascular disorder or active intracranial pathology

MEDICATIONS

* Administration of a fibrinolytic agent within 7 days
* Known allergy or contraindication to eptifibatide OR aspirin OR heparin
* Treatment with another GP IIb/IIIa inhibitor within 7 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schering-Plough

INDUSTRY

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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C. Michael Gibson, MS, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eugene Braunwald, M.D.

Role: STUDY_CHAIR

The TIMI Study Group

C. Michael Gibson, M.D.

Role: PRINCIPAL_INVESTIGATOR

The TIMI Study Group

Locations

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Cardiology Research Associates

Ormond Beach, Florida, United States

Site Status

Crittenton Hospital Medical Center

Rochester, Michigan, United States

Site Status

Mid Ohio Heart Clinic

Mansfield, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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T101

Identifier Type: -

Identifier Source: org_study_id