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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,038
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
Number of participants With use of thrombolytic agent in catheterization lab
Time frame: Day 1
Time spent in catheterization lab
Time frame: Day 1
Number of balloon Used inflations during angioplasty
Time frame: Day 1
Number of Successful Angioplasty
Time frame: Day 1
Reason for Specific Mortality
Time frame: Up to end of study (30 days after angioplasty)
Number of participants with late major clinical events
Time frame: 30 days after angioplasty up to 6 months after angioplasty
Number of Abrupt Closure
Time frame: Day 1
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