A Phase 4 interventional study of Abciximab in Coronary Artery Disease and Ischemia, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-02-26.
Sponsored by Laval University · Phase 4, Interventional, and Treatment
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 1,000 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
CLINICAL:
ANGIOGRAPHIC
Death, Q & non-Q myocardial infarction (MI), urgent revascularization, repeat hospitalization, severe thrombocytopenia, access site complications, major bleedings, at 30-days.
Death, Q & non-Q MI, repeat target vessel revascularization at 30-days, 6 and 12 mo. Length of hospital stay & unsolicited medical visits at 30-days. Patient satisfaction within 24 hrs and at 30 days, 6 and 12 mo. Direct/indirect cost.
This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.
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