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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
• Treatments: Abciximab; Anti-Inflammatory Agents; Antibodies, Monoclonal; Immunoglobulin Fab Fragments

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.