Status:
COMPLETED
A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab
Lead Sponsor:
Centocor, Inc.
Conditions:
Angioplasty, Transluminal, Percutaneous Coronary
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief 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...
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and effectiveness of intracoronary stenting with or without abciximab, an anti-platelet therapy, and con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 1997
Estimated Enrollment :
2399 Patients enrolled
Trial Details
Trial ID
NCT00271401
Start Date
July 1 1996
End Date
September 1 1997
Last Update
May 25 2015
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