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

Primary Purpose

Angina, Unstable, Angioplasty, Transluminal, Percutaneous Coronary

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Abciximab
Placebo
Sponsored by
Centocor, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina, Unstable focused on measuring Abciximab, Angina, unstable, Angioplasty, transluminal, Percutaneous coronary

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Placebo

    Abciximab and Placebo

    Abciximab

    Arm Description

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

    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.

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

    Outcomes

    Primary Outcome Measures

    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 Measures

    Number of participants With use of thrombolytic agent in catheterization lab
    Time 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

    Full Information

    First Posted
    December 22, 2005
    Last Updated
    June 1, 2015
    Sponsor
    Centocor, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00269893
    Brief Title
    A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty
    Official Title
    A Phase III Double-Blind, Placebo-Controlled Multicenter Study of Abciximab In Patients Undergoing High Risk Coronary Angioplasty (EPIC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1991 (undefined)
    Primary Completion Date
    November 1992 (Actual)
    Study Completion Date
    November 1992 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centocor, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Angina, Unstable, Angioplasty, Transluminal, Percutaneous Coronary
    Keywords
    Abciximab, Angina, unstable, Angioplasty, transluminal, Percutaneous coronary

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    2038 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive matching placebo solution bolus followed by matching placebo solution infusion up to 12 hours.
    Arm Title
    Abciximab and Placebo
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Abciximab
    Arm Type
    Experimental
    Arm Description
    Participants will receive 0.25 mg/kg of body weight of abciximab bolus followed by abciximab (c7E3 Fab) infusion up to 12 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    Abciximab
    Other Intervention Name(s)
    c7E3 Fab
    Intervention Description
    0.25 mg/kg of body weight of abciximab either bolus or infusion.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching Placebo soulution either bolus or infusion.
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    Number of participants With use of thrombolytic agent in catheterization lab
    Time Frame
    Day 1
    Title
    Time spent in catheterization lab
    Time Frame
    Day 1
    Title
    Number of balloon Used inflations during angioplasty
    Time Frame
    Day 1
    Title
    Number of Successful Angioplasty
    Time Frame
    Day 1
    Title
    Reason for Specific Mortality
    Time Frame
    Up to end of study (30 days after angioplasty)
    Title
    Number of participants with late major clinical events
    Time Frame
    30 days after angioplasty up to 6 months after angioplasty
    Title
    Number of Abrupt Closure
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Centocor, Inc. Clinical Trial
    Organizational Affiliation
    Centocor, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    8121459
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    9256222
    Citation
    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.
    Results Reference
    result

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

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