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

ST-Elevation Myocardial Infarction Clinical Trial

— CICERO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00927615
• Other study ID #: 200807
• Status: Active, not recruiting
• Phase: N/A
• First received: June 24, 2009
• Last updated: September 7, 2010
• Start date: September 2008
• Est. completion date: April 2011

Study information

• Verified date: March 2010
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 534
• Est. completion date: April 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-Elevation Myocardial Infarction

Intervention

Drug:
• abciximab
0.25 mg/kg body weight (intracoronary)
• abciximab
0.25 mg/kg body weight (intravenous)

Locations

Country	Name	City	State
Netherlands	University Medical Centre Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of ST-segment resolution >70%		30 to 60 minutes post-PCI	No
Secondary	Bleeding complications		in-hospital	Yes
Secondary	Thrombolysis In Myocardial Infarction (TIMI) flow		post-PCI	No
Secondary	Myocardial Blush Grade (MBG)		post-PCI	No
Secondary	Incidence of distal embolization		post-PCI	No
Secondary	persistent residual ST-segment deviation		30 to 60 minutes post-PCI	No
Secondary	enzymatic infarct size		in-hospital	No
Secondary	Major Adverse Cardiac Events (MACE)		30 days	No