Status:
COMPLETED
A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty
Lead Sponsor:
Centocor, Inc.
Conditions:
Angina, Unstable
Angioplasty, Transluminal, Percutaneous Coronary
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of abciximab (an anti-platelet therapy) versus placebo in patients undergoing high risk coronary angioplasty.
Detailed Description
This is a randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of abciximab, an anti-platelet therapy, in patients undergoing high risk coronary angioplas...
Eligibility Criteria
Inclusion
- Patients referred for elective or urgent coronary balloon angioplasty or atherectomy with an FDA-approved device in one of the following settings: unstable angina or non-Q wave myocardial infarction, acute Q-wave myocardial infarction, or high-risk clinical/morphological characteristics
Exclusion
- Patients with a history of hemorrhagic diathesis - Having had major surgery or clinically significant gastrointestinal or genitourinary bleeding within 6 weeks of study enrollment
- Having had a stroke within 2 years prior to enrollment or any stroke with significant residual neurological deficit
- Having occlusion of the left main coronary artery greater than 50% or a history of vasculitis
- Treated with oral anticoagulants within 7 days (unless prothrombin time is =\< 1.2 times control) or intravenous dextran (before or planned for during the treatment angioplasty)
Key Trial Info
Start Date :
November 1 1991
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 1992
Estimated Enrollment :
2038 Patients enrolled
Trial Details
Trial ID
NCT00269893
Start Date
November 1 1991
End Date
November 1 1992
Last Update
June 2 2015
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