Comparison of Intracoronary Versus Intravenous Abciximab in ST-segment Elevation Myocardial Infarction (CICERO)
- Registration Number
- NCT00927615
- Lead Sponsor
- University Medical Center Groningen
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 534
a diagnosis of STEMI defined by
- chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission
- time from onset of symptoms of less than 12 hours
- ECG with ST-segment deviation of more than 0.1 mV in 2 or more leads
- rescue PCI after thrombolytic therapy
- need for emergency coronary artery bypass grafting
- presence of cardiogenic shock
- known existence of a life-threatening disease with a life expectancy of less than 6 months
- inability to provide informed consent
- contra-indications for the use of abciximab (active internal bleeding, history of stroke within 2 years, recent major surgery or intracranial or intraspinal trauma or surgery within 2 months, intracranial neoplasm, arteriovenous malformation or aneurysm, bleeding diathesis, severe uncontrolled hypertension, thrombocytopenia, vasculitis, hypertensive or diabetic retinopathy, severe liver or kidney failure, and hypersensitivity to murine proteins)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intracoronary abciximab abciximab intracoronary administration of abciximab (0.25 mg/kg body weight) intravenous abciximab abciximab intravenous administration of abciximab (0.25 mg/kg body weight)
- Primary Outcome Measures
Name Time Method incidence of ST-segment resolution >70% 30 to 60 minutes post-PCI
- Secondary Outcome Measures
Name Time Method Bleeding complications in-hospital Thrombolysis In Myocardial Infarction (TIMI) flow post-PCI Myocardial Blush Grade (MBG) post-PCI Incidence of distal embolization post-PCI persistent residual ST-segment deviation 30 to 60 minutes post-PCI enzymatic infarct size in-hospital Major Adverse Cardiac Events (MACE) 30 days
Trial Locations
- Locations (1)
University Medical Centre Groningen
🇳🇱Groningen, Netherlands