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A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-Platelet Therapy, in Patients With Unstable Angina Not Responding to Standard Medical Therapy Who Are Eligible for 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 Angina, unstable, Angioplasty, transluminal, percutaneous coronary, Abciximab

Eligibility Criteria

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

Inclusion Criteria: Patients with refractory angina as evidenced by at least one episode of ischemia (chest pain and/or ST-T changes) despite bed rest and at least 2 hours of treatment with oral or intravenous nitrates and intravenous heparin, or persistent newly developed negative T-waves occurring or continuing after at least 2 hours of treatment with oral or intravenous nitrates and intravenous heparin Having clinical signs and symptoms of angina at rest or minimal exertion with dynamic ST-segment and/or T-wave changes Having an episode of chest pain within 48 hours prior to the start of study agent administration Having a culprit lesion in a single native coronary vessel suitable for angioplasty on the qualifying angiogram Exclusion Criteria: Patients who have had a recent myocardial infarction, unless CK has returned to less than twice the upper limit of normal Having features of ongoing ischemia that would require immediate intervention, or had a percutaneous transluminal coronary angioplasty (PTCA) within the past 24 hours Having an unprotected occlusion of the main left coronary artery > 50%, a culprit lesion located in a venous or arterial bypass graft, or recent bleeding or a condition associated with increased bleeding risk Receiving concurrent administration of oral anticoagulants at the time of study entry, administration of intravenous dextran (prior to or planned for use during angioplasty), or planned administration of thrombolytic agent prior to or during angioplasty Having persistent hypertension at admission despite treatment, or a platelet count less than 100,000 per millimeter cubed

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Abciximab (c7E3 Fab)

    Placebo

    Arm Description

    Participants will receive 0.25 milligram per kilogram (mg/kg) of body weight abciximab as bolus intravenous injection followed by continuous infusion of abciximab at rate of 10 microgram per minute for at least 18 hours but not longer than 26 hours.

    Participants will receive matching placebo as bolus IV injection followed by continuous infusion of matching placebo for at least 18 hours but no longer than 26 hours.

    Outcomes

    Primary Outcome Measures

    Number of Participants who Died From Any Cause
    Number of Participant with any one of these: Myocardial Infraction, Recurrent Ischemic Events Requiring Urgent Intervention (Coronary Artery Bypass Surgery, Repeat Coronary Angioplasty, Coronary Stent Placement, Intra-aortic Balloon Pump)

    Secondary Outcome Measures

    Number of Participants With New Ischemia
    Number of Participants With PTCA Complications
    Number of Participants With use of Thrombolytic Agents in the Catheterization
    Number of Participants With use of a Balloon Perfusion Catheter During Procedure
    Number of Particpants With Late Major Clinical Events

    Full Information

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

    Unique Protocol Identification Number
    NCT00269906
    Brief Title
    A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-Platelet Therapy, in Patients With Unstable Angina Not Responding to Standard Medical Therapy Who Are Eligible for Coronary Angioplasty
    Official Title
    Chimeric Anti-Platelet Therapy (Abciximab) in Unstable Angina Refractory to Standard Medical Therapy Trial (CAPTURE)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1993 (undefined)
    Primary Completion Date
    December 1995 (Actual)
    Study Completion Date
    December 1995 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and efficacy of abciximab, an anti-platelet therapy, versus placebo in patients with unstable angina who are not responding to standard medical therapy and who are eligible for coronary angioplasty.
    Detailed Description
    This is a randomized, placebo-controlled study to evaluate the safety and efficacy of abciximab, an anti-platelet therapy, in patients with unstable angina who are not responding to standard medical therapy and who are eligible for coronary angioplasty. The primary outcomes of the study include any of the following within 30 days: the number of deaths from any cause, myocardial infarctions or the number of recurrent ischemic events requiring urgent intervention (such as a coronary artery bypass surgery, repeat coronary angioplasty, coronary stent placement, or intra-aortic balloon pump). Please see attached results. Patients will be treated with abciximab or matching 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
    Angina, unstable, Angioplasty, transluminal, percutaneous coronary, Abciximab

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1265 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Abciximab (c7E3 Fab)
    Arm Type
    Experimental
    Arm Description
    Participants will receive 0.25 milligram per kilogram (mg/kg) of body weight abciximab as bolus intravenous injection followed by continuous infusion of abciximab at rate of 10 microgram per minute for at least 18 hours but not longer than 26 hours.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive matching placebo as bolus IV injection followed by continuous infusion of matching placebo for at least 18 hours but no longer than 26 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    Abciximab
    Other Intervention Name(s)
    c7E3 Fab
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Number of Participants who Died From Any Cause
    Time Frame
    Up to 30 Days
    Title
    Number of Participant with any one of these: Myocardial Infraction, Recurrent Ischemic Events Requiring Urgent Intervention (Coronary Artery Bypass Surgery, Repeat Coronary Angioplasty, Coronary Stent Placement, Intra-aortic Balloon Pump)
    Time Frame
    Up to 30 Days
    Secondary Outcome Measure Information:
    Title
    Number of Participants With New Ischemia
    Time Frame
    From onset of infusion to percutaneous transluminal coronary angioplasty (PTCA), and from PTCA through 24 hours after PTCA
    Title
    Number of Participants With PTCA Complications
    Time Frame
    From onset of infusion to PTCA, and from PTCA through 24 hours after PTCA
    Title
    Number of Participants With use of Thrombolytic Agents in the Catheterization
    Time Frame
    Day 1
    Title
    Number of Participants With use of a Balloon Perfusion Catheter During Procedure
    Time Frame
    Day 1
    Title
    Number of Particpants With Late Major Clinical Events
    Time Frame
    From Day 30 up to 6 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with refractory angina as evidenced by at least one episode of ischemia (chest pain and/or ST-T changes) despite bed rest and at least 2 hours of treatment with oral or intravenous nitrates and intravenous heparin, or persistent newly developed negative T-waves occurring or continuing after at least 2 hours of treatment with oral or intravenous nitrates and intravenous heparin Having clinical signs and symptoms of angina at rest or minimal exertion with dynamic ST-segment and/or T-wave changes Having an episode of chest pain within 48 hours prior to the start of study agent administration Having a culprit lesion in a single native coronary vessel suitable for angioplasty on the qualifying angiogram Exclusion Criteria: Patients who have had a recent myocardial infarction, unless CK has returned to less than twice the upper limit of normal Having features of ongoing ischemia that would require immediate intervention, or had a percutaneous transluminal coronary angioplasty (PTCA) within the past 24 hours Having an unprotected occlusion of the main left coronary artery > 50%, a culprit lesion located in a venous or arterial bypass graft, or recent bleeding or a condition associated with increased bleeding risk Receiving concurrent administration of oral anticoagulants at the time of study entry, administration of intravenous dextran (prior to or planned for use during angioplasty), or planned administration of thrombolytic agent prior to or during angioplasty Having persistent hypertension at admission despite treatment, or a platelet count less than 100,000 per millimeter cubed
    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
    9164316
    Citation
    Randomised placebo-controlled trial of abciximab before and during coronary intervention in refractory unstable angina: the CAPTURE Study. Lancet. 1997 May 17;349(9063):1429-35. Erratum In: Lancet 1997 Sep 6;350(9079):744.
    Results Reference
    result

    Learn more about this trial

    A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-Platelet Therapy, in Patients With Unstable Angina Not Responding to Standard Medical Therapy Who Are Eligible for Coronary Angioplasty

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