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.

Phase 3

Completed

• Conditions: Angioplasty, Transluminal, Percutaneous Coronary
• Interventions: Drug: Heparin; Drug: Placebo; Drug: Abciximab

• Registration Number: NCT00269880
• Lead Sponsor: Centocor, Inc.

Brief Summary

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

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

Study Timeline

• Study Start: 1995-02
• Primary Completion: 1995-12
• Study Completion: 1995-12
• Study First Submitted: 2005-12-22
• Study First Submitted QC: 2005-12-22
• Study First Posted: 2005-12-26
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-22
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2792

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

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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%

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abciximab and Standard Dose Heparin	Abciximab	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.
Abciximab and Low Dose of Heparin	Heparin	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.
Abciximab and Standard Dose Heparin	Heparin	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.
Placebo and Standard Dose of Heparin	Placebo	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.
Placebo and Standard Dose of Heparin	Heparin	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.
Abciximab and Low Dose of Heparin	Abciximab	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Angiographic outcome; death, MI or target vessel revascularization within 6 months; death or MI within 6 months; health economic analyses	up to 6 months