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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Centocor, Inc.

Current Primary Outcome: 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). [ Time Frame: 30 days after angioplasty ]

Original Primary Outcome: 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).

Current Secondary Outcome:

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


Original Secondary Outcome: Abrupt closure; Use of thrombolytic agents in the catheterization lab; Time in catheterization lab; Number of balloon inflations during angioplasty; Angioplasty success; Cause specific mortality

Information By: Centocor, Inc.

Dates:
Date Received: December 22, 2005
Date Started: November 1991
Date Completion:
Last Updated: June 1, 2015
Last Verified: June 2015