Trial | NCT00269893  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    abciximab ...

  • Study Participants

    2038
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.
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 Started
Nov 30
1991
Primary Completion
Nov 30
1992
Study Completion
Nov 30
1992
Last Update
Jun 02
2015
Estimate

Drug Abciximab

0.25 mg/kg of body weight of abciximab either bolus or infusion.

  • Other names: c7E3 Fab

Drug Placebo

Matching Placebo soulution either bolus or infusion.

Placebo Placebo Comparator

Participants will receive matching placebo solution bolus followed by matching placebo solution infusion up to 12 hours.

Abciximab and Placebo Experimental

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.

Abciximab Experimental

Participants will receive 0.25 mg/kg of body weight of abciximab bolus followed by abciximab (c7E3 Fab) infusion up to 12 hours.

Criteria 

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)
No Results Posted