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

Phase 4

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: Intracoronary administration of an abciximab bolus during primary PCI; Drug: Intravenous administration of an abciximab bolus during primary PCI

• Registration Number: NCT01757457
• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

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.

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 Timeline

• Study Start: 2006-04
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2012-12
• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-28
• Last Update Submitted: 2012-12-28
• Study First Posted: 2012-12-31
• Last Update Posted: 2012-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracoronary abciximab	Intracoronary administration of an abciximab bolus during primary PCI	Intracoronary administration of an abciximab bolus during primary PCI
Intravenous abciximab	Intravenous administration of an abciximab bolus during primary PCI	Intravenous standard administration of an abciximab bolus during primary PCI

Primary Outcome Measures

Name	Time	Method
Change in C-reactive protein levels from baseline after PCI	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

Name	Time	Method
Overall Mortality	1year	Mortality for all causes at 1year after primary PCI
Target vessel revascularization	1 year	Target vessel revascularization at 1 year after primary PCI
Myocardial infarction	1 year	Recurrent Myocardial infarction 1 year after PCI

Trial Locations

Locations (1)

Ospedale Maggiore della Carità; 🇮🇹 Novara, Piedmont, Italy