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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00927615
Recruitment Status : Unknown
Verified March 2010 by University Medical Center Groningen.
Recruitment status was:  Active, not recruiting
First Posted : June 25, 2009
Last Update Posted : September 8, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
ST-Elevation Myocardial Infarction Drug: abciximab Not Applicable

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  (Clinical Trial)
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 : September 2008
Actual Primary Completion Date : May 2010
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Abciximab
U.S. FDA Resources

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 Name: 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 Name: ReoPro

Primary Outcome Measures :
  1. incidence of ST-segment resolution >70% [ Time Frame: 30 to 60 minutes post-PCI ]

Secondary Outcome Measures :
  1. Bleeding complications [ Time Frame: in-hospital ]
  2. Thrombolysis In Myocardial Infarction (TIMI) flow [ Time Frame: post-PCI ]
  3. Myocardial Blush Grade (MBG) [ Time Frame: post-PCI ]
  4. Incidence of distal embolization [ Time Frame: post-PCI ]
  5. persistent residual ST-segment deviation [ Time Frame: 30 to 60 minutes post-PCI ]
  6. enzymatic infarct size [ Time Frame: in-hospital ]
  7. Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00927615

University Medical Centre Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Principal Investigator: Felix Zijlstra, MD PhD University Medical Center Groningen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: F. Zijlstra, University Medical Centre Groningen Identifier: NCT00927615     History of Changes
Other Study ID Numbers: 200807
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: September 8, 2010
Last Verified: March 2010

Keywords provided by University Medical Center Groningen:
myocardial infarction
glycoprotein IIb/IIIa
percutaneous coronary intervention
thrombus aspiration
myocardial perfusion

Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Antibodies, Monoclonal
Immunoglobulin Fab Fragments
Platelet Aggregation Inhibitors
Immunologic Factors
Physiological Effects of Drugs