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.

Centocor, Inc.2,792 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,792

Conditions

Angioplasty, Transluminal, Percutaneous Coronary

Interventions

PlaceboDRUG

Placebo is administered as bolus or 12 hour infusion prior to index percutaneous coronary intervention.

HeparinDRUG

Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.

AbciximabDRUG

Abciximab is administered as bolus followed by 12 hour infusion prior to index percutaneous coronary intervention.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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%

Outcomes

Primary Outcomes

Death, myocardial infarction, or repeat revascularization within 6 months

Time frame: 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

Time frame: Up to 30 Days

Secondary Outcomes

Angiographic outcome; death, MI or target vessel revascularization within 6 months; death or MI within 6 months; health economic analyses

Time frame: up to 6 months

Data from ClinicalTrials.gov

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