NCT00927615

Comparison of Intracoronary Versus Intravenous Abciximab in ST-segment Elevation Myocardial Infarction (CICERO)

Coronary Versus Intravenous abCiximab Administration During Emergency Reperfusion Of ST-segment Elevation Myocardial Infarction - the CICERO Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 534 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• ST-Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	abciximab	0.25 mg/kg body weight (intracoronary)
DRUG	abciximab	0.25 mg/kg body weight (intravenous)

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-05-01
• Completion: 2011-04-01
• First posted: 2009-06-25
• Last updated: 2010-09-08

Locations

1 site across 1 country: Netherlands