A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab
Information source: Centocor, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Angioplasty, Transluminal, Percutaneous Coronary
Intervention: Abciximab/angioplasty, abciximab/stent, placebo/stent (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Centocor, Inc. Official(s) and/or principal investigator(s):
Centocor, Inc. Clinical Trial, Study Director, Affiliation: Centocor, Inc.
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.
Clinical Details
Official title: A Multicenter, Randomized Trial Evaluating 30-Day and 6-Month Clinical Outcomes With Three Different Treatment Strategies (Coronary Angioplasty + Abciximab, Intracoronary Stent + Abciximab, and Intracoronary Stent + Placebo) in Patients Undergoing Percutaneous Coronary Intervention
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Composite of deaths, myocardial infarctions, or urgent repeat revascularizations within 30 days of randomization
Secondary outcome: Six-month clinical outcome; Six-month angiographic outcome as determined by quantitative coronary angiography in a subgroup of patients; Health economic analyses of medical costs, medical resource consumption, and cost effectiveness
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 conventional coronary angioplasty with abciximab in patients
undergoing percutaneous coronary intervention. Patients will be randomly assigned to one of
three treatment groups: coronary angioplasty plus abciximab, intracoronary stent plus
abciximab, or intracoronary stent plus placebo. The primary measures of effectiveness will
be a 30-day composite, clinical outcome as determined by the number of deaths, myocardial
infarctions, or urgent repeat revascularizations. Please see attached results.
Patients will receive one of three different treatments: Coronary angioplasty plus abciximab;
Intracoronary stent plus abciximab; or Intracoronary stent plus placebo.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Last updated: April 6, 2007
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