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

Sponsor

University Medical Center Groningen (Other)

Overall Status

Unknown status

CT.gov ID

NCT00927615

Collaborator

(none)

534

Enrollment

Location

Arms

30.9

Duration (Months)

17.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ST-Elevation Myocardial Infarction	Drug: abciximab Drug: abciximab	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

534 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

May 1, 2010

Anticipated Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intracoronary abciximab intracoronary administration of abciximab (0.25 mg/kg body weight)	Drug: abciximab 0.25 mg/kg body weight (intracoronary) Other Names: ReoPro
Active Comparator: intravenous abciximab intravenous administration of abciximab (0.25 mg/kg body weight)	Drug: abciximab 0.25 mg/kg body weight (intravenous) Other Names: ReoPro

Arm

Intervention/Treatment

Experimental: intracoronary abciximab

intracoronary administration of abciximab (0.25 mg/kg body weight)

Drug: abciximab

0.25 mg/kg body weight (intracoronary)

Other Names:

ReoPro

Active Comparator: intravenous abciximab

intravenous administration of abciximab (0.25 mg/kg body weight)

Drug: abciximab

0.25 mg/kg body weight (intravenous)

Other Names:

ReoPro

Outcome Measures

Primary Outcome Measures

incidence of ST-segment resolution >70% [30 to 60 minutes post-PCI]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)