Trial | NCT01757457  Report issue

Title

Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention
Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention.(Molecole di Adesione Nella Sindrome Coronarica Acuta

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    abciximab ...

  • Study Participants

    89
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.
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 Started
Apr 30
2006
Primary Completion
Apr 30
2008
Study Completion
Apr 30
2008
Last Update
Dec 31
2012
Estimate

Drug Intracoronary administration of an abciximab bolus during primary PCI

Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) 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

Intracoronary abciximab Experimental

Intracoronary administration of an abciximab bolus during primary PCI

Intravenous abciximab Active Comparator

Intravenous standard administration of an abciximab bolus during primary PCI

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.
No Results Posted