A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty
- Conditions
- Angioplasty, Transluminal, Percutaneous CoronaryAngina, Unstable
- Interventions
- Drug: Placebo
- Registration Number
- NCT00269893
- Lead Sponsor
- Centocor, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2038
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abciximab and Placebo Abciximab 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 Abciximab Participants will receive 0.25 mg/kg of body weight of abciximab bolus followed by abciximab (c7E3 Fab) infusion up to 12 hours. Placebo Placebo Participants will receive matching placebo solution bolus followed by matching placebo solution infusion up to 12 hours. Abciximab and Placebo Placebo 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.
- Primary Outcome Measures
Name Time Method 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). 30 days after angioplasty
- Secondary Outcome Measures
Name Time Method Number of participants With use of thrombolytic agent in catheterization lab Day 1 Time spent in catheterization lab Day 1 Number of balloon Used inflations during angioplasty Day 1 Number of Successful Angioplasty Day 1 Reason for Specific Mortality Up to end of study (30 days after angioplasty) Number of Abrupt Closure Day 1 Number of participants with late major clinical events 30 days after angioplasty up to 6 months after angioplasty