A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab
May 22, 2015 updated by: Centocor, Inc.
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
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
2399
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Angioplasty With Abciximab Plus Low-Dose Heparin
Participants will receive conventional angioplasty/atherectomy along with bolus abciximab 0.25 milligram per kilogram (mg/kg) of body weight followed by a 0.125 microgram per kilogram per minute (mcg/kg/minute) infusion for 12 hours plus 7 unit per kilogram per hour (U/kg/hr) continuous infusion of heparin.
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Experimental: Intracoronary Stent With Reo Pro Plus Low Dose Heparin
Participants will receive intracoronary stent along with receive bolus abciximab 0.25 mg/kg of body weight followed by a 0.125 mcg/kg/minute infusion for 12 hours plus 7 U/kg/hr continuous infusion of heparin (low dose).
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Placebo Comparator: Intracoronary Stent With Placebo Plus Standard Dose Heparin
Participants will receive intracoronary stent along with bolus placebo followed by placebo infusion for 12 hours plus 10 U/kg/hr continuous infusion of heparin (standard dose).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations
Time Frame: Up to 30 days
|
Up to 30 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Particpants with Angiographic Outcome, Death or Myocardial Infraction and Cardiovascular Functional Status
Time Frame: Up to 6 months
|
Up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Topol EJ, Mark DB, Lincoff AM, Cohen E, Burton J, Kleiman N, Talley D, Sapp S, Booth J, Cabot CF, Anderson KM, Califf RM. Outcomes at 1 year and economic implications of platelet glycoprotein IIb/IIIa blockade in patients undergoing coronary stenting: results from a multicentre randomised trial. EPISTENT Investigators. Evaluation of Platelet IIb/IIIa Inhibitor for Stenting. Lancet. 1999 Dec 11;354(9195):2019-24. doi: 10.1016/s0140-6736(99)10018-7. Erratum In: Lancet 2000 Mar 25;355(9209):1104.
- EPISTENT Investigators. Randomised placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade. Lancet. 1998 Jul 11;352(9122):87-92. doi: 10.1016/s0140-6736(98)06113-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1996
Primary Completion (Actual)
September 1, 1997
Study Completion (Actual)
September 1, 1997
Study Registration Dates
First Submitted
December 30, 2005
First Submitted That Met QC Criteria
December 30, 2005
First Posted (Estimate)
January 2, 2006
Study Record Updates
Last Update Posted (Estimate)
May 25, 2015
Last Update Submitted That Met QC Criteria
May 22, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR006265
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