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

September 7, 2010 updated by: University Medical Center Groningen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

534

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Centre Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Drug: abciximab
0.25 mg/kg body weight (intravenous)
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 (intracoronary)
Other Names:
  • ReoPro
Drug: abciximab
0.25 mg/kg body weight (intravenous)
Other Names:
  • ReoPro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of ST-segment resolution >70%
Time Frame: 30 to 60 minutes post-PCI
30 to 60 minutes post-PCI

Secondary Outcome Measures

Outcome Measure
Time Frame
Major Adverse Cardiac Events (MACE)
Time Frame: 30 days
30 days
Bleeding complications
Time Frame: in-hospital
in-hospital
Thrombolysis In Myocardial Infarction (TIMI) flow
Time Frame: post-PCI
post-PCI
Myocardial Blush Grade (MBG)
Time Frame: post-PCI
post-PCI
Incidence of distal embolization
Time Frame: post-PCI
post-PCI
persistent residual ST-segment deviation
Time Frame: 30 to 60 minutes post-PCI
30 to 60 minutes post-PCI
enzymatic infarct size
Time Frame: in-hospital
in-hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Felix Zijlstra, MD PhD, University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

June 24, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimate)

June 25, 2009

Study Record Updates

Last Update Posted (Estimate)

September 8, 2010

Last Update Submitted That Met QC Criteria

September 7, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200807

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ST-Elevation Myocardial Infarction

Clinical Trials on abciximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe