NCT00269893

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,038 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Angina, Unstable
• Angioplasty, Transluminal, Percutaneous Coronary

Interventions

Type	Name	Description
DRUG	Abciximab	0.25 mg/kg of body weight of abciximab either bolus or infusion.
DRUG	Placebo	Matching Placebo soulution either bolus or infusion.

Timeline

• Start date: 1991-11-01
• Primary completion: 1992-11-01
• Completion: 1992-11-01
• First posted: 2005-12-26
• Last updated: 2015-06-02