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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757457
• Other study ID #: 0000004
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2012
• Last updated: December 28, 2012
• Start date: April 2006
• Est. completion date: April 2008

Study information

• Verified date: December 2012
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myocardial Infarction

Intervention

Drug:
• Intracoronary administration of an abciximab bolus during primary PCI
Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI
• Intravenous administration of an abciximab bolus during primary PCI
Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI

Locations

Country	Name	City	State
Italy	Ospedale Maggiore della Carità	Novara	Piedmont

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Overall Mortality	Mortality for all causes at 1year after primary PCI	1year	Yes
Secondary	Target vessel revascularization	Target vessel revascularization at 1 year after primary PCI	1 year	Yes
Secondary	Myocardial infarction	Recurrent Myocardial infarction 1 year after PCI	1 year	Yes