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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	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

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	89 participants
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
Study Start Date :	April 2006
Actual Primary Completion Date :	April 2008
Actual Study Completion Date :	April 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. Overall Mortality [ Time Frame: 1year ]
   Mortality for all causes at 1year after primary PCI
2. Target vessel revascularization [ Time Frame: 1 year ]
   Target vessel revascularization at 1 year after primary PCI
3. Myocardial infarction [ Time Frame: 1 year ]
   Recurrent Myocardial infarction 1 year after PCI

Eligibility Criteria

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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

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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

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Secco GG, Sansa M, Rognoni A, Parisi R, Fattori R, Rossi L, Lazzero M, Rolla R, Bellomo G, Bongo AS, Agostoni P, Di Mario C, Lupi A. Similar anti-inflammatory effects of intracoronary and intravenous abciximab during primary percutaneous coronary intervention: a randomized study. J Cardiovasc Med (Hagerstown). 2015 Mar;16(3):189-96. doi: 10.2459/JCM.0000000000000119.

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 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