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

Phase 2

Terminated

• Conditions: ST-Elevation Myocardial Infarction
• Interventions: Drug: normal saline; Drug: eptifibatide

• Registration Number: NCT00719914
• Lead Sponsor: Brigham and Women's Hospital

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.

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).

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-07-18
• Study First Posted: 2008-07-22
• Primary Completion: 2008-11
• Study Completion: 2009-01
• Status Verified: 2012-07
• Results First Submitted: 2012-07-24
• Results First Submitted QC: 2012-07-24
• Last Update Submitted: 2012-07-24
• Results First Posted: 2012-08-27
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	normal saline	Intra-coronary injection of normal saline.
1	eptifibatide	Intracoronary injection of eptifibatide

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Mid Ohio Heart Clinic; 🇺🇸 Mansfield, Ohio, United States

Crittenton Hospital Medical Center; 🇺🇸 Rochester, Michigan, United States

Cardiology Research Associates; 🇺🇸 Ormond Beach, Florida, United States