A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab
NCT ID: NCT00271401
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
2399 participants
INTERVENTIONAL
1996-07-31
1997-09-30
Brief Summary
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Detailed Description
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Patients will receive one of three different treatments: Coronary angioplasty plus abciximab; Intracoronary stent plus abciximab; or Intracoronary stent plus placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Angioplasty
Abxicimab
Heparin
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).
Intracoronary Stent
Abxicimab
Heparin
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).
Intracoronary Stent
Heparin
Placebo
Interventions
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Angioplasty
Intracoronary Stent
Abxicimab
Heparin
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
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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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.
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.
Other Identifiers
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CR006265
Identifier Type: -
Identifier Source: org_study_id
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