A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness and safety of abciximab (an anti-platelet therapy) versus placebo in patients undergoing high risk coronary angioplasty.

Detailed Description
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This is a randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of abciximab, an anti-platelet therapy, in patients undergoing high risk coronary angioplasty. The primary outcomes of the study include any of the following: the number of deaths from any cause, or myocardial infarctions and recurrent ischemic events requiring urgent intervention (e.g., repeat angioplasty, coronary artery bypass surgery, intracoronary stent placement, or intra-aortic balloon pump). Patients receive an abciximab bolus, abciximab bolus plus infusion, or placebo.

Official Title
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A Phase III Double-Blind, Placebo-Controlled Multicenter Study of Abciximab In Patients Undergoing High Risk Coronary Angioplasty (EPIC)

Conditions
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Angina, Unstable, Angioplasty, Transluminal, Percutaneous Coronary

Intervention / Treatment
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* Drug: Abciximab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred for elective or urgent coronary balloon angioplasty or atherectomy with an FDA-approved device in one of the following settings: unstable angina or non-Q wave myocardial infarction, acute Q-wave myocardial infarction, or high-risk clinical/morphological characteristics Exclusion Criteria: Patients with a history of hemorrhagic diathesis - Having had major surgery or clinically significant gastrointestinal or genitourinary bleeding within 6 weeks of study enrollment Having had a stroke within 2 years prior to enrollment or any stroke with significant residual neurological deficit Having occlusion of the left main coronary artery greater than 50% or a history of vasculitis Treated with oral anticoagulants within 7 days (unless prothrombin time is =< 1.2 times control) or intravenous dextran (before or planned for during the treatment angioplasty)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants will receive matching placebo solution bolus followed by matching placebo solution infusion up to 12 hours. | Drug: Placebo<br>* Matching Placebo soulution either bolus or infusion.<br>|
| Experimental: Abciximab and Placebo<br>Participants will receive 0.25 milligram per kilogram (mg/kg) of body weight of abciximab (c7E3 Fab) bolus injection followed by followed by placebo solution infusion up to 12 hours. | Drug: Abciximab<br>* 0.25 mg/kg of body weight of abciximab either bolus or infusion.<br>* Other names: c7E3 Fab;Drug: Placebo<br>* Matching Placebo soulution either bolus or infusion.<br>|
| Experimental: Abciximab<br>Participants will receive 0.25 mg/kg of body weight of abciximab bolus followed by abciximab (c7E3 Fab) infusion up to 12 hours. | Drug: Abciximab<br>* 0.25 mg/kg of body weight of abciximab either bolus or infusion.<br>* Other names: c7E3 Fab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any of the following within 30 days: Death from any cause; Myocardial infarction; Recurrent ischemic event requiring urgent intervention (repeat angioplasty, coronary artery bypass surgery, intracoronary stent placement, or intra-aortic balloon pump). |  | 30 days after angioplasty | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants With use of thrombolytic agent in catheterization lab |  | Day 1 | 
| Time spent in catheterization lab |  | Day 1 | 
| Number of balloon Used inflations during angioplasty |  | Day 1 | 
| Number of Successful Angioplasty |  | Day 1 | 
| Reason for Specific Mortality |  | Up to end of study (30 days after angioplasty) | 
| Number of participants with late major clinical events |  | 30 days after angioplasty up to 6 months after angioplasty | 
| Number of Abrupt Closure |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abciximab, Angina, unstable, Angioplasty, transluminal, Percutaneous coronary