Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 11:33 PM
Study NCT ID:
NCT00269893
Status:
COMPLETED
Last Update Posted:
2015-06-02
First Post:
2005-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty
Sponsor:
Organization:
Raw JSON
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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.'}, {'pmid': '9256222', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nPatients receive an abciximab bolus, abciximab bolus plus infusion, or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Patients with a history of hemorrhagic diathesis - Having had major surgery or clinically significant gastrointestinal or genitourinary bleeding within 6 weeks of study enrollment\n* Having had a stroke within 2 years prior to enrollment or any stroke with significant residual neurological deficit\n* Having occlusion of the left main coronary artery greater than 50% or a history of vasculitis\n* 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)'}, 'identificationModule': {'nctId': 'NCT00269893', 'briefTitle': 'A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centocor, Inc.'}, 'officialTitle': 'A Phase III Double-Blind, Placebo-Controlled Multicenter Study of Abciximab In Patients Undergoing High Risk Coronary Angioplasty (EPIC)', 'orgStudyIdInfo': {'id': 'CR006268'}, 'secondaryIdInfos': [{'id': 'C0116T09', 'type': 'OTHER', 'domain': 'Centocor'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive matching placebo solution bolus followed by matching placebo solution infusion up to 12 hours.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Abciximab and Placebo', '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.', 'interventionNames': ['Drug: Abciximab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Abciximab', 'description': 'Participants will receive 0.25 mg/kg of body weight of abciximab bolus followed by abciximab (c7E3 Fab) infusion up to 12 hours.', 'interventionNames': ['Drug: Abciximab']}], 'interventions': [{'name': 'Abciximab', 'type': 'DRUG', 'otherNames': ['c7E3 Fab'], 'description': '0.25 mg/kg of body weight of abciximab either bolus or infusion.', 'armGroupLabels': ['Abciximab', 'Abciximab and Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching Placebo soulution either bolus or infusion.', 'armGroupLabels': ['Abciximab and Placebo', 'Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Centocor, Inc. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centocor, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centocor, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}