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Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01757457
First Posted: December 31, 2012
Last Update Posted: December 31, 2012
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.
Information provided by (Responsible Party):
Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita
  Purpose
Intracoronary abciximab administration during primary percutaneous coronary intervention (pPCI) could offer clinical advantages over the intravenous route. The aim of this study was to assess whether abciximab administration route could influence its anti-inflammatory effects. 87 consecutive STEMI patients candidate to pPCI were randomized to receive an intracoronary or intravenous abciximab bolus. The primary endpoint was the extent of inflammation, measured by C-reactive protein (CRP), VCAM-1 and ICAM-1 levels.

Condition Intervention Phase
Myocardial Infarction Drug: Intracoronary administration of an abciximab bolus during primary PCI Drug: Intravenous administration of an abciximab bolus during primary PCI Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention.(Molecole di Adesione Nella Sindrome Coronarica Acuta

Resource links provided by NLM:


Further study details as provided by Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita:

Primary Outcome Measures:
  • Change in C-reactive protein levels from baseline after PCI [ Time Frame: 48h ]
    C-reactive protein will be evaluated at admission and 48 hours after the primary PCI as marker of the inflammatory reaction


Secondary Outcome Measures:
  • Overall Mortality [ Time Frame: 1year ]
    Mortality for all causes at 1year after primary PCI

  • Target vessel revascularization [ Time Frame: 1 year ]
    Target vessel revascularization at 1 year after primary PCI

  • Myocardial infarction [ Time Frame: 1 year ]
    Recurrent Myocardial infarction 1 year after PCI


Enrollment: 89
Study Start Date: April 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intracoronary abciximab
Intracoronary administration of an abciximab bolus during primary PCI
Drug: Intracoronary administration of an abciximab bolus during primary PCI
Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI
Active Comparator: Intravenous abciximab
Intravenous standard administration of an abciximab bolus during primary PCI
Drug: Intravenous administration of an abciximab bolus during primary PCI
Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI

Detailed Description:

BACKGROUND: intracoronary abciximab administration during primary percutaneous coronary intervention (pPCI) could offer clinical advantages over the intravenous route. Besides antiplatelet effects, abciximab can modulate inflammation via cross-reactivity with GPIIb/IIIa, avb3, and aMb2 receptors. The aim of this study was to assess whether abciximab administration route could influence its anti-inflammatory effects.

METHODS: 87 consecutive STEMI patients candidate to pPCI were randomized to receive intracoronary (Group A, 47 patients) or intravenous (Group B, 42 patients) abciximab bolus. The primary endpoint was the extent of inflammation, measured by C-reactive protein (CRP), VCAM-1 and ICAM-1 levels.

  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of STEMI according to the universal definition of myocardial infarction (7);
  • hospital admission within 12 hours from symptom onset;
  • successful treatment by primary PCI, defined as a procedure achieving infarct-related artery (IRA) patency with less than 10% residual coronary stenosis based on visual estimation.

Exclusion Criteria:

  • age > 90 years;
  • cardiogenic shock at admission;
  • left main as IRA;
  • saphenous vein graft as IRA;
  • previous PCI in the last 6 months;
  • severe renal impairment (eGFR<30ml/min) or dialysis treatment;
  • thrombolytic drug administration in the last 30 days before admission;
  • known malignancy diagnosed less than 5 years before admission;
  • known active infectious, coagulative or systemic inflammatory diseases.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01757457


Locations
Italy
Ospedale Maggiore della Carità
Novara, Piedmont, Italy, 28100
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
Investigators
Principal Investigator: Alessandro Lupi, MD AO Maggiore della Carita
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lupi Alessandro, Principal Investigator, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT01757457     History of Changes
Other Study ID Numbers: 0000004
First Submitted: December 19, 2012
First Posted: December 31, 2012
Last Update Posted: December 31, 2012
Last Verified: December 2012

Keywords provided by Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita:
inflammation
thrombosis
platelets
adhesion molecules
endothelium

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents
Abciximab
Antibodies, Monoclonal
Immunoglobulin Fab Fragments
Anticoagulants
Platelet Aggregation Inhibitors
Immunologic Factors
Physiological Effects of Drugs