A Study Comparing the Efficacy and Safety of Abciximab, an Anti-Platelet Therapy, in Combination With Two Different Heparin Regimens in Patients Undergoing Percutaneous Coronary Intervention.

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and effectiveness of abciximab, an anti-platelet therapy, versus placebo in patients undergoing percutaneous coronary intervention when administered in combination with two different heparin regimens. Please see attached results.

Detailed Description
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This is a randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of abciximab, an anti-platelet therapy, in combination with two different heparin regimens in patients undergoing percutaneous coronary intervention. Patients will be randomly assigned to one of three treatment groups: abciximab/low-dose weight-adjusted heparin, abciximab/standard-dose weight-adjusted heparin, or placebo/standard-dose weight-adjusted heparin. The primary outcomes of the study include the number of deaths, myocardial infarctions, or repeat revascularizations within 6 months, and the number of deaths, myocardial infarctions, or severe myocardial ischemia leading to urgent repeat percutaneous coronary intervention or urgent coronary artery bypass surgery within 30 days. Please see attached results. Abciximab bolus plus 12-hour infusion with standard-dose weight-adjusted heparin; Abciximab bolus plus 12-hour infusion with low-dose weight-adjusted heparin; Placebo bolus plus 12-hour infusion with standard-dose weight-adjusted heparin

Official Title
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A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Clinical Outcomes Following Percutaneous Coronary Intervention in Patients Treated With an Abciximab Bolus Plus 12-Hour Infusion Given With Either Standard-Dose Weight-Adjusted Heparin or Low-Dose Weight-Adjusted Heparin

Conditions
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Angioplasty, Transluminal, Percutaneous Coronary

Intervention / Treatment
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* Drug: Placebo
* Drug: Heparin
* Drug: Abciximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred for elective or urgent percutaneous coronary intervention with an FDA-approved device Having a target artery (native or graft) stenosis of 60% by visual estimation Exclusion Criteria: Patients with unstable angina/non-Q-wave myocardial infarction meeting EPIC criteria within the previous 24 hours, or with acute Q-wave myocardial infarction meeting EPIC criteria with onset of chest pain within previous 24 hours With active internal bleeding, having a condition that may increase the risk of bleeding, or currently receiving administration of oral anticoagulants at the time of study entry With confirmed hypertension with systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg Having had a percutaneous coronary intervention within the previous 3 months Having an unprotected left main coronary artery stenosis > 50%

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 |
| --- | --- |
| Placebo Comparator: Placebo and Standard Dose of Heparin<br>Participants will receive bolus placebo followed by 12-hour infusion of placebo and bolus heparin at a dose of 100 units per kilogram of body weight. | Drug: Placebo<br>* Placebo is administered as bolus or 12 hour infusion prior to index percutaneous coronary intervention.<br>Drug: Heparin<br>* Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.<br>|
| Active Comparator: Abciximab and Low Dose of Heparin<br>Participants will receive bolus abciximab at a dose of 0.25 milligram per kilogram (mg/kg) of body weight followed by 12-hour infusion of 0.125 microgram per kilogram per minute (mcg/kg/min) and bolus heparin at a dose of 70 units per kilogram of body weight. | Drug: Heparin<br>* Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.<br>Drug: Abciximab<br>* Abciximab is administered as bolus followed by 12 hour infusion prior to index percutaneous coronary intervention.<br>|
| Active Comparator: Abciximab and Standard Dose Heparin<br>Participants will receive bolus abciximab at a dose of 0.25 mg/kg of body weight followed by 12-hour infusion of 0.125 mcg/kg/min and bolus heparin at a dose of 100 units per kilogram of body weight. | Drug: Heparin<br>* Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.<br>Drug: Abciximab<br>* Abciximab is administered as bolus followed by 12 hour infusion prior to index percutaneous coronary intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death, myocardial infarction, or repeat revascularization within 6 months |  | up to 6 months | 
| Death, myocardial infarction, or severe myocardial ischemia leading to urgent repeat percutaneous coronary intervention or urgent coronary artery bypass surgery within 30 days |  | Up to 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic outcome; death, MI or target vessel revascularization within 6 months; death or MI within 6 months; health economic analyses |  | up to 6 months | 

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