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

Study Overview
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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).

Official Title
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IntraCoronary Treatment With Integrilin To Improve ANgiographic Outcomes (IC TITAN - TIMI 47) Trial

Conditions
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ST-Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: eptifibatide
* Drug: eptifibatide
* Drug: normal saline


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Intracoronary injection of eptifibatide | Drug: eptifibatide<br>* Intra-coronary injection, weight based, of eptifibatide.<br>Drug: eptifibatide<br>* Intra-coronary injection, based on weight, of eptifibatide<br>|
| Placebo Comparator: 2<br>Intra-coronary injection of normal saline. | Drug: normal saline<br>* Intra-coronary injection, weight based, of normal saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eptifibatide, Integrilin, ST-Elevation Myocardial Infarction, Acute Myocardial Infarction