A Phase 3 interventional study of Abciximab and Placebo in Angina, Unstable and Angioplasty, Transluminal, Percutaneous Coronary, sponsored by Centocor, Inc.. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-06-02.
Sponsored by Centocor, Inc. · Phase 3, Interventional, and Treatment
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.
276 studies on the registry are indexed under Angina, Unstable; 36 are open to participants now.
This study's enrollment of 2,038 is above the median of 188 across 173 interventional studies indexed under Angina, Unstable.
Browse Angina, Unstable studies →Centocor, Inc. is the lead sponsor of 73 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive matching placebo solution bolus followed by matching placebo solution infusion up to 12 hours.
Drug: 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.
Drug: Abciximab · Drug: Placebo
Participants will receive 0.25 mg/kg of body weight of abciximab bolus followed by abciximab (c7E3 Fab) infusion up to 12 hours.
Drug: Abciximab
0.25 mg/kg of body weight of abciximab either bolus or infusion.
Also known as: c7E3 Fab
Matching Placebo soulution either bolus or infusion.
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
No study locations are listed for this record.
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Centocor, Inc.