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

• Status: Completed
• Trial end date: 1997-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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

• 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