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

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

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.

Study Overview

• Status: Completed
• Conditions: Angina, Unstable; Angioplasty, Transluminal, Percutaneous Coronary
• Intervention / Treatment: Drug: Placebo; Drug: Abciximab

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 2038
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive matching placebo solution bolus followed by matching placebo solution infusion up to 12 hours.	Drug: Placebo; Matching Placebo soulution either bolus or infusion.
Experimental: Abciximab and Placebo; 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: Placebo; Matching Placebo soulution either bolus or infusion.; Drug: Abciximab; 0.25 mg/kg of body weight of abciximab either bolus or infusion.; Other Names: c7E3 Fab
Experimental: Abciximab; 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; 0.25 mg/kg of body weight of abciximab either bolus or infusion.; Other Names: c7E3 Fab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centocor, Inc.

Publications and helpful links

General Publications

• EPIC Investigators. Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. N Engl J Med. 1994 Apr 7;330(14):956-61. doi: 10.1056/NEJM199404073301402.
• Topol EJ, Ferguson JJ, Weisman HF, Tcheng JE, Ellis SG, Kleiman NS, Ivanhoe RJ, Wang AL, Miller DP, Anderson KM, Califf RM. Long-term protection from myocardial ischemic events in a randomized trial of brief integrin beta3 blockade with percutaneous coronary intervention. EPIC Investigator Group. Evaluation of Platelet IIb/IIIa Inhibition for Prevention of Ischemic Complication. JAMA. 1997 Aug 13;278(6):479-84. doi: 10.1001/jama.278.6.479.

Study record dates

Study Major Dates

• Study Start: November 1, 1991
• Primary Completion (Actual): November 1, 1992
• Study Completion (Actual): November 1, 1992

Study Registration Dates

• First Submitted: December 22, 2005
• First Submitted That Met QC Criteria: December 22, 2005
• First Posted (Estimate): December 26, 2005

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Angina, unstable; Abciximab; Angioplasty, transluminal, Percutaneous coronary
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Unstable; Platelet Aggregation Inhibitors; Anticoagulants; Abciximab
• Other Study ID Numbers: CR006268; C0116T09 (Other Identifier: Centocor)