A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab
Phase 3
Completed
- Conditions
- Angioplasty, Transluminal, Percutaneous Coronary
- Interventions
- Registration Number
- NCT00271401
- Lead Sponsor
- Centocor, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2399
Inclusion Criteria
- Patients referred for elective or urgent percutaneous coronary intervention
- Who are suitable candidates for either conventional angioplasty or primary intracoronary stent implantation
- Having a target artery (native or graft) stenosis of >= 60% (visual estimation)
Exclusion Criteria
- Patients with acute ST-segment elevation myocardial infarction within the previous 12 hours
- With a planned staged procedure or having an unprotected left main coronary artery stenosis > 50%
- With active internal bleeding, having a condition that may increase the risk of bleeding, or receiving ongoing treatment with an oral anticoagulant at the time of study entry
- Having had a percutaneous coronary intervention within the previous 3 months or prior intracoronary stent placement in a target vessel
- Having hypertension with systolic blood pressure > 180 mm Hg or diastolic blood pressure > 100 mm Hg at the time of study entry, or a platelet count < 100,000/μL at baseline
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Angioplasty With Abciximab Plus Low-Dose Heparin Heparin Participants will receive conventional angioplasty/atherectomy along with bolus abciximab 0.25 milligram per kilogram (mg/kg) of body weight followed by a 0.125 microgram per kilogram per minute (mcg/kg/minute) infusion for 12 hours plus 7 unit per kilogram per hour (U/kg/hr) continuous infusion of heparin. Angioplasty With Abciximab Plus Low-Dose Heparin Angioplasty Participants will receive conventional angioplasty/atherectomy along with bolus abciximab 0.25 milligram per kilogram (mg/kg) of body weight followed by a 0.125 microgram per kilogram per minute (mcg/kg/minute) infusion for 12 hours plus 7 unit per kilogram per hour (U/kg/hr) continuous infusion of heparin. Angioplasty With Abciximab Plus Low-Dose Heparin Abxicimab Participants will receive conventional angioplasty/atherectomy along with bolus abciximab 0.25 milligram per kilogram (mg/kg) of body weight followed by a 0.125 microgram per kilogram per minute (mcg/kg/minute) infusion for 12 hours plus 7 unit per kilogram per hour (U/kg/hr) continuous infusion of heparin. Intracoronary Stent With Reo Pro Plus Low Dose Heparin Intracoronary Stent Participants will receive intracoronary stent along with receive bolus abciximab 0.25 mg/kg of body weight followed by a 0.125 mcg/kg/minute infusion for 12 hours plus 7 U/kg/hr continuous infusion of heparin (low dose). Intracoronary Stent With Reo Pro Plus Low Dose Heparin Abxicimab Participants will receive intracoronary stent along with receive bolus abciximab 0.25 mg/kg of body weight followed by a 0.125 mcg/kg/minute infusion for 12 hours plus 7 U/kg/hr continuous infusion of heparin (low dose). Intracoronary Stent With Placebo Plus Standard Dose Heparin Intracoronary Stent Participants will receive intracoronary stent along with bolus placebo followed by placebo infusion for 12 hours plus 10 U/kg/hr continuous infusion of heparin (standard dose). Intracoronary Stent With Placebo Plus Standard Dose Heparin Placebo Participants will receive intracoronary stent along with bolus placebo followed by placebo infusion for 12 hours plus 10 U/kg/hr continuous infusion of heparin (standard dose). Intracoronary Stent With Reo Pro Plus Low Dose Heparin Heparin Participants will receive intracoronary stent along with receive bolus abciximab 0.25 mg/kg of body weight followed by a 0.125 mcg/kg/minute infusion for 12 hours plus 7 U/kg/hr continuous infusion of heparin (low dose). Intracoronary Stent With Placebo Plus Standard Dose Heparin Heparin Participants will receive intracoronary stent along with bolus placebo followed by placebo infusion for 12 hours plus 10 U/kg/hr continuous infusion of heparin (standard dose).
- Primary Outcome Measures
Name Time Method Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations Up to 30 days
- Secondary Outcome Measures
Name Time Method Number of Particpants with Angiographic Outcome, Death or Myocardial Infraction and Cardiovascular Functional Status Up to 6 months