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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University Medical Centre Groningen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00927615
First received: June 24, 2009
Last updated: September 7, 2010
Last verified: March 2010
  Purpose

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 Intervention
ST-Elevation Myocardial Infarction
Drug: abciximab

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Coronary Versus Intravenous abCiximab Administration During Emergency Reperfusion Of ST-segment Elevation Myocardial Infarction - the CICERO Trial

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • incidence of ST-segment resolution >70% [ Time Frame: 30 to 60 minutes post-PCI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bleeding complications [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ]
  • Thrombolysis In Myocardial Infarction (TIMI) flow [ Time Frame: post-PCI ] [ Designated as safety issue: No ]
  • Myocardial Blush Grade (MBG) [ Time Frame: post-PCI ] [ Designated as safety issue: No ]
  • Incidence of distal embolization [ Time Frame: post-PCI ] [ Designated as safety issue: No ]
  • persistent residual ST-segment deviation [ Time Frame: 30 to 60 minutes post-PCI ] [ Designated as safety issue: No ]
  • enzymatic infarct size [ Time Frame: in-hospital ] [ Designated as safety issue: No ]
  • Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 534
Study Start Date: September 2008
Estimated Study Completion Date: April 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927615

Locations
Netherlands
University Medical Centre Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Felix Zijlstra, MD PhD University Medical Centre Groningen
  More Information

No publications provided by University Medical Centre Groningen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: F. Zijlstra, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT00927615     History of Changes
Other Study ID Numbers: 200807
Study First Received: June 24, 2009
Last Updated: September 7, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Abciximab
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014