Clinical trial NCT01757457: Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention
Official title: Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention.(Molecole di Adesione Nella Sindrome Coronarica Acuta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: inflammation
thrombosis
platelets
adhesion molecules
endothelium
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2012-12-31
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in C-reactive protein levels from baseline after PCI
timeFrame: 48h
Secondary outcomes:
measure: Overall Mortality
timeFrame: 1year
measure: Target vessel revascularization
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 1 year
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Ospedale Maggiore della Carità
state: Piedmont
Study officials:
affiliation: AO Maggiore della Carita
name: Alessandro Lupi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.