A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Participants will receive matching placebo solution bolus followed by matching placebo solution infusion up to 12 hours. |
Drug: Placebo
Matching Placebo soulution either bolus or infusion.
|
| Experimental: Abciximab and 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
0.25 mg/kg of body weight of abciximab either bolus or infusion.
Other Names:
Drug: Placebo
Matching Placebo soulution either bolus or infusion.
|
| Experimental: Abciximab 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 participants with late major clinical events [30 days after angioplasty up to 6 months after angioplasty]
- Number of Abrupt Closure [Day 1]
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
-
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)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Centocor, Inc.
Investigators
- Study Director: Centocor, Inc. Clinical Trial, Centocor, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR006268
- C0116T09