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Sponsors and Collaborators: |
Laval University Eli Lilly and Company Bristol-Myers Squibb |
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Information provided by: | Laval University |
ClinicalTrials.gov Identifier: | NCT00169819 |
HYPOTHESES
OBJECTIVES AND END-POINTS
The objectives of the present study are to assess the effectiveness and safety of same day hospital discharge after uncomplicated coronary artery stenting when a single bolus of Abciximab is used. The primary end-point of the study is the composite of death, myocardial infarction, repeat hospitalization, urgent revascularization, severe thrombocytopenia, access site complications and major bleedings at 30 days following stent implantation.
The secondary end-point is the composite of death, myocardial infarction, repeat target vessel revascularization at 30 days, 6 months and 1 year following stent implantation. Other secondary end-points include the total hospital stay (days) between the index procedure and the first 30 days follow-up, the number of unsolicited medical visits in relation with the percutaneous procedure, index of patient satisfaction and direct and indirect costs.
Condition | Intervention | Phase |
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Coronary Artery Disease Ischemia |
Drug: Abciximab |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial Comparing Same Day Discharge and a Single Bolus of Abciximab to Overnight Hospitalization and Bolus + Perfusion Abciximab After Uncomplicated Trans-Radial Coronary Artery Stenting |
Estimated Enrollment: | 1000 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | April 2006 |
Despite significant improvements in clinical results associated with the current use of stenting and pharmacologic agents there has been little modification in hospitalization duration after percutaneous coronary interventions (PCI). The main reasons associated with prolonged hospitalization after PCI remain 1) the fear of abrupt vessel closure and its associated morbidity 2) the need for prolonged bed rest in case of femoral approach even after use of device closures.
The introduction of coronary stents has been associated with a dramatic decrease in vessel closure once it was recognized that stent deployment required higher pressure balloon inflation and increased antiplatelet therapy. Trans-radial coronary interventions appear safer and more cost-effective than femoral PCI. However, the current use of IIb-IIIa inhibitors prohibits the early discharge of patients following PCI because their pharmacology generally imposes to pursue drug infusion between 18 and 24 hrs following PCI which does not allow same day discharge from the hospital. With Abciximab, however, pharmacologic data indicate that prolonged platelet inhibition (≥ 80%) occurs after a single bolus. Based on the EPIC trial results, it has been recommended to prolong platelet inhibition by a 12 hrs perfusion. By analyzing carefully the EPIC trial results, we hypothesized that after optimal stenting result, a single bolus of Abciximab would suffice. We aim to demonstrate that (1) with trans-radial coronary stenting at least 50% of the entire population referred for PCI could be safely discharged after a few hours observation; (2) a single bolus of Abciximab is at least as effective as current recommended treatment with a bolus + 12 hrs perfusion after uncomplicated stenting. This new regimen could significantly affect current practice, decrease hospital costs and increase patient satisfaction after PCI.
STUDY DESIGN
A prospective randomized single-center study comparing same day hospital discharge to overnight hospitalization after uncomplicated trans-radial coronary artery stenting. Out-patients will be randomized after successful stent implantation to same day discharge or will remain hospitalized at Laval Hospital until the next morning. Hospitalized patients will be randomized after successful stent implantation to either same day discharge at home or to overnight hospitalization (either at the referring center or at Laval Hospital). All eligible patients will be treated with Abciximab that will be administered according to 2 different arms: For patients randomized to same-day discharge, only a bolus of Abciximab will be given, whereas for all remaining patients, Abciximab will be given according to current practice i.e. bolus + 12 hrs perfusion. All patients which will not be eligible post-PCI will enter a registry.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
CLINICAL:
ANGIOGRAPHIC
Canada, Quebec | |
Laval Hospital Research Center | |
Sainte-Foy, Quebec, Canada, G1V 4G5 |
Principal Investigator: | Olivier F Bertrand, MD, PhD | Laval Hospital Research Center |
Study ID Numbers: | H4S-CA-0050, ISRCTN72335887 |
Study First Received: | September 9, 2005 |
Last Updated: | February 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00169819 |
Health Authority: | Canada: Health Canada |
Same day discharge Trans-radial Coronary artery stenting Abciximab bolus |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases |
Abciximab Arteriosclerosis Ischemia Coronary Artery Disease |
Anticoagulants Pathologic Processes Therapeutic Uses Hematologic Agents |
Platelet Aggregation Inhibitors Cardiovascular Diseases Pharmacologic Actions |