Status:
COMPLETED
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.
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 safety and effectiveness of abciximab, an anti-platelet therapy, versus placebo in patients undergoing percutaneous coronary intervention when administered ...
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 un...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
February 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1995
Estimated Enrollment :
2792 Patients enrolled
Trial Details
Trial ID
NCT00269880
Start Date
February 1 1995
End Date
December 1 1995
Last Update
May 25 2015
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