Angina, Unstable, Angioplasty, Transluminal, Percutaneous Coronary
Conditions
Keywords
Abciximab, Angina, unstable, Angioplasty, transluminal, Percutaneous coronary
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.
Interventions
DRUGAbciximab
0.25 mg/kg of body weight of abciximab either bolus or infusion.
DRUGPlacebo
Matching Placebo soulution either bolus or infusion.
Sponsors
Centocor, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Time spent in catheterization lab | Day 1 |
| Number of balloon Used inflations during angioplasty | Day 1 |
| Number of Successful Angioplasty | Day 1 |
| Number of participants With use of thrombolytic agent in catheterization lab | Day 1 |
| Number of participants with late major clinical events | 30 days after angioplasty up to 6 months after angioplasty |
| Number of Abrupt Closure | Day 1 |
| Reason for Specific Mortality | Up to end of study (30 days after angioplasty) |
Outcome results
None listed