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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Drug: Intracoronary administration of an abciximab bolus during primary PCI; Drug: Intravenous administration of an abciximab bolus during primary PCI

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 Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Piedmont
    • Novara, Piedmont, Italy, 28100
      • Ospedale Maggiore della Carità

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in C-reactive protein levels from baseline after PCI	C-reactive protein will be evaluated at admission and 48 hours after the primary PCI as marker of the inflammatory reaction	48h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Mortality	Mortality for all causes at 1year after primary PCI	1year
Target vessel revascularization	Target vessel revascularization at 1 year after primary PCI	1 year
Myocardial infarction	Recurrent Myocardial infarction 1 year after PCI	1 year

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (ACTUAL): April 1, 2008
• Study Completion (ACTUAL): April 1, 2008

Study Registration Dates

• First Submitted: December 19, 2012
• First Submitted That Met QC Criteria: December 28, 2012
• First Posted (ESTIMATE): December 31, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 31, 2012
• Last Update Submitted That Met QC Criteria: December 28, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: inflammation; platelets; thrombosis; endothelium; adhesion molecules
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Platelet Aggregation Inhibitors; Anticoagulants; Abciximab
• Other Study ID Numbers: 0000004