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
Overview
- Phase
- Phase 3
- Intervention
- Intracoronary Stent
- Conditions
- Angioplasty, Transluminal, Percutaneous Coronary
- Sponsor
- Centocor, Inc.
- Enrollment
- 2399
- Primary Endpoint
- Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Intracoronary Stent With Reo Pro Plus Low Dose 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).
Intervention: Intracoronary Stent
Angioplasty With Abciximab Plus Low-Dose 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.
Intervention: Angioplasty
Angioplasty With Abciximab Plus Low-Dose 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.
Intervention: Abxicimab
Angioplasty With Abciximab Plus Low-Dose 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.
Intervention: Heparin
Intracoronary Stent With Reo Pro Plus Low Dose 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).
Intervention: Abxicimab
Intracoronary Stent With Reo Pro Plus Low Dose 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).
Intervention: Heparin
Intracoronary Stent With Placebo Plus Standard Dose 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).
Intervention: Intracoronary Stent
Intracoronary Stent With Placebo Plus Standard Dose 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).
Intervention: Heparin
Intracoronary Stent With Placebo Plus Standard Dose 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).
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations
Time Frame: Up to 30 days
Secondary Outcomes
- Number of Particpants with Angiographic Outcome, Death or Myocardial Infraction and Cardiovascular Functional Status(Up to 6 months)