Current partner codePEPTIDESDE
NCT00719914·Phase 2·INTERVENTIONAL

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

Status

Terminated

Phase

Phase 2

Enrollment

31

Locations

3

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

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).

Interventions

Treatment arms and agents.

DRUG

eptifibatide

Intra-coronary injection, weight based, of eptifibatide.

DRUG

eptifibatide

Intra-coronary injection, based on weight, of eptifibatide

DRUG

normal saline

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

Timeline

From registration to results.

  1. First posted

    Jul 22, 2008

  2. Study start

    Nov 2007

  3. Primary completion

    Nov 2008

  4. Study completion

    Jan 2009

  5. Results posted

    Aug 27, 2012

  6. Registry updated

    Aug 27, 2012

Outcomes

What the study measures.

Primary outcomes

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)

Time frame · 30 days

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

3 registered sites.

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

Cardiology Research Associates

Ormond Beach, Florida, United States

Crittenton Hospital Medical Center

Rochester, Michigan, United States

Mid Ohio Heart Clinic

Mansfield, Ohio, United States

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.