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.
NCT ID: NCT00269880
Last Updated: 2015-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2792 participants
INTERVENTIONAL
1995-02-28
1995-12-31
Brief Summary
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Detailed Description
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Abciximab bolus plus 12-hour infusion with standard-dose weight-adjusted heparin; Abciximab bolus plus 12-hour infusion with low-dose weight-adjusted heparin; Placebo bolus plus 12-hour infusion with standard-dose weight-adjusted heparin
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo and Standard Dose of Heparin
Participants will receive bolus placebo followed by 12-hour infusion of placebo and bolus heparin at a dose of 100 units per kilogram of body weight.
Placebo
Placebo is administered as bolus or 12 hour infusion prior to index percutaneous coronary intervention.
Heparin
Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.
Abciximab and Low Dose of Heparin
Participants will receive bolus abciximab at a dose of 0.25 milligram per kilogram (mg/kg) of body weight followed by 12-hour infusion of 0.125 microgram per kilogram per minute (mcg/kg/min) and bolus heparin at a dose of 70 units per kilogram of body weight.
Heparin
Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.
Abciximab
Abciximab is administered as bolus followed by 12 hour infusion prior to index percutaneous coronary intervention.
Abciximab and Standard Dose Heparin
Participants will receive bolus abciximab at a dose of 0.25 mg/kg of body weight followed by 12-hour infusion of 0.125 mcg/kg/min and bolus heparin at a dose of 100 units per kilogram of body weight.
Heparin
Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.
Abciximab
Abciximab is administered as bolus followed by 12 hour infusion prior to index percutaneous coronary intervention.
Interventions
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Placebo
Placebo is administered as bolus or 12 hour infusion prior to index percutaneous coronary intervention.
Heparin
Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.
Abciximab
Abciximab is administered as bolus followed by 12 hour infusion prior to index percutaneous coronary intervention.
Eligibility Criteria
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Inclusion Criteria
* Having a target artery (native or graft) stenosis of 60% by visual estimation
Exclusion Criteria
* 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%
21 Years
ALL
No
Sponsors
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Centocor, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Centocor, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Centocor, Inc.
References
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Lincoff AM, Mark DB, Tcheng JE, Califf RM, Bala MV, Anderson KM, Davidson-Ray L, Knight JD, Cabot CF, Topol EJ. Economic assessment of platelet glycoprotein IIb/IIIa receptor blockade with abciximab and low-dose heparin during percutaneous coronary revascularization: results from the EPILOG randomized trial. Evaluation in PTCA to Improve Long-term Outcome with abciximab GP IIb/IIIa blockade. Circulation. 2000 Dec 12;102(24):2923-9. doi: 10.1161/01.cir.102.24.2923.
Lincoff AM, Tcheng JE, Califf RM, Kereiakes DJ, Kelly TA, Timmis GC, Kleiman NS, Booth JE, Balog C, Cabot CF, Anderson KM, Weisman HF, Topol EJ. Sustained suppression of ischemic complications of coronary intervention by platelet GP IIb/IIIa blockade with abciximab: one-year outcome in the EPILOG trial. Evaluation in PTCA to Improve Long-term Outcome with abciximab GP IIb/IIIa blockade. Circulation. 1999 Apr 20;99(15):1951-8. doi: 10.1161/01.cir.99.15.1951.
EPILOG Investigators. Platelet glycoprotein IIb/IIIa receptor blockade and low-dose heparin during percutaneous coronary revascularization. N Engl J Med. 1997 Jun 12;336(24):1689-96. doi: 10.1056/NEJM199706123362401.
Related Links
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A Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) Effects on the QT Interval in Subjects with Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma
Other Identifiers
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CR006262
Identifier Type: -
Identifier Source: org_study_id
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