A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty
Information source: Centocor, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Angina, Unstable; Angioplasty, Transluminal, Percutaneous Coronary
Intervention: Abciximab (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Centocor, Inc. Official(s) and/or principal investigator(s): Centocor, Inc. Clinical Trial, Study Director, Affiliation: Centocor, Inc.
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.
Clinical Details
Official title: A Phase III Double-Blind, Placebo-Controlled Multicenter Study of Abciximab In Patients Undergoing High Risk Coronary Angioplasty (EPIC)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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).
Secondary outcome: Number of participants With use of thrombolytic agent in catheterization labTime spent in catheterization lab Number of balloon Used inflations during angioplasty Number of Successful Angioplasty Reason for Specific Mortality Number of participants with late major clinical events Number of Abrupt Closure
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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)
Locations and Contacts
Additional Information
Starting date: November 1991
Last updated: June 1, 2015
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