A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab
The purpose of this study is to compare the effectiveness and safety of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention.
Angioplasty, Transluminal, Percutaneous Coronary
Drug: Abciximab/angioplasty, abciximab/stent, placebo/stent
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized Trial Evaluating 30-day and 6-month Clinical Outcomes With Three Different Treatment Strategies (Coronary Angioplasty + Abciximab, Intracoronary Stent + Abciximab, and Intracoronary Stent + Placebo) in Patients Undergoing Percutaneous Coronary Intervention|
- Composite of deaths, myocardial infarctions, or urgent repeat revascularizations within 30 days of randomization
- Six-month clinical outcome; Six-month angiographic outcome as determined by quantitative coronary angiography in a subgroup of patients; Health economic analyses of medical costs, medical resource consumption, and cost effectiveness
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and effectiveness of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention. Patients will be randomly assigned to one of three treatment groups: coronary angioplasty plus abciximab, intracoronary stent plus abciximab, or intracoronary stent plus placebo. The primary measures of effectiveness will be a 30-day composite, clinical outcome as determined by the number of deaths, myocardial infarctions, or urgent repeat revascularizations. Please see attached results.
Patients will receive one of three different treatments: Coronary angioplasty plus abciximab; Intracoronary stent plus abciximab; or Intracoronary stent plus placebo.