A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Angioplasty, Transluminal, Percutaneous Coronary

Intervention / Treatment
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* Other: Angioplasty
* Other: Intracoronary Stent
* Drug: Abxicimab
* Drug: Heparin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Angioplasty With Abciximab Plus Low-Dose Heparin<br>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. | Other: Angioplasty<br> <br> Drug: Abxicimab<br> <br> Drug: Heparin<br> <br> |
| Experimental: Intracoronary Stent With Reo Pro Plus Low Dose Heparin<br>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). | Other: Intracoronary Stent<br> <br> Drug: Abxicimab<br> <br> Drug: Heparin<br> <br> |
| Placebo Comparator: Intracoronary Stent With Placebo Plus Standard Dose Heparin<br>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). | Other: Intracoronary Stent<br> <br> Drug: Heparin<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations |  | Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Particpants with Angiographic Outcome, Death or Myocardial Infraction and Cardiovascular Functional Status |  | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stents, Angioplasty, Transluminal, Percutaneous Coronary