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

NCT ID: NCT00927615

Last Updated: 2010-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 534 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-04-30

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.

Conditions

ST-Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intracoronary abciximab

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

Group Type: EXPERIMENTAL

abciximab

Intervention Type: DRUG

0.25 mg/kg body weight (intracoronary)

intravenous abciximab

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

Group Type: ACTIVE_COMPARATOR

abciximab

Intervention Type: DRUG

0.25 mg/kg body weight (intravenous)

Interventions

abciximab

0.25 mg/kg body weight (intracoronary)

Intervention Type: DRUG

abciximab

0.25 mg/kg body weight (intravenous)

Intervention Type: DRUG

Other Intervention Names

ReoPro; ReoPro

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

University Medical Centre Groningen

Principal Investigators

Felix Zijlstra, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

References

Gu YL, Fokkema ML, Kampinga MA, de Smet BJ, Tan ES, van den Heuvel AF, Zijlstra F. Intracoronary versus intravenous abciximab in ST-segment elevation myocardial infarction: rationale and design of the CICERO trial in patients undergoing primary percutaneous coronary intervention with thrombus aspiration. Trials. 2009 Sep 28;10:90. doi: 10.1186/1745-6215-10-90.

Reference Type: DERIVED

PMID: 19785725 (View on PubMed)

Other Identifiers

200807

Identifier Type: -

Identifier Source: org_study_id