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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,265
Number of Participants who Died From Any Cause
Time frame: Up to 30 Days
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
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
Number of Participants With PTCA Complications
Time frame: From onset of infusion to PTCA, and from PTCA through 24 hours after PTCA
Number of Participants With use of Thrombolytic Agents in the Catheterization
Time frame: Day 1
Number of Participants With use of a Balloon Perfusion Catheter During Procedure
Time frame: Day 1
Number of Particpants With Late Major Clinical Events
Time frame: From Day 30 up to 6 Months
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