ST-Elevation Myocardial Infarction Clinical Trial
Official title:
Coronary Versus Intravenous abCiximab Administration During Emergency Reperfusion Of ST-segment Elevation Myocardial Infarction - the CICERO Trial
The primary objective of this study is to investigate whether intracoronary bolus administration of abciximab is superior to intravenous bolus administration in improving myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.
The contemporary management of ST-segment elevation myocardial infarction (STEMI) consists
of primary percutaneous coronary intervention (PCI) including thrombus aspiration and
stenting. There is, however, still a high incidence of impaired post-procedural myocardial
perfusion, which is associated with poorer clinical outcomes. Intravenous (IV)
administration of the glycoprotein IIb/IIIa inhibitor abciximab during primary PCI plays an
important role in the treatment of patients with STEMI. With higher local drug
concentrations, abciximab may have additional anti-platelet, anti-thrombotic and
anti-inflammatory features. These possible benefits may be obtained by intracoronary (IC)
administration of abciximab. Recent small- to medium-scaled studies have suggested that IC
administration of abciximab instead of the (IV) route is associated with improved
post-procedural myocardial perfusion and a clinically relevant reduction of major adverse
cardiac events.
Because of the limited number of patients included in these studies, a larger randomized
clinical trial is needed to evaluate the effect of IC abciximab in patients with STEMI.
Furthermore, the combined strategy of PCI with thrombus aspiration and IC use of abciximab
has not been investigated.
Therefore, the investigators intend to evaluate the effect of IC bolus administration of
abciximab compared to IV bolus administration on post-procedural myocardial perfusion as
assessed by the extent of ST-segment elevation resolution in patients with STEMI undergoing
primary PCI. The study is a single-center, prospective, randomized trial with blinded
evaluation of endpoints.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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