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.

• Status: Completed
• Trial end date: 1995-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor, Inc.
• Treatments: Abciximab; Antibodies, Monoclonal; Calcium heparin; Heparin; Immunoglobulin Fab Fragments

Criteria

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%