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Completed

NCT Number: NCT01757457

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ospedale Maggiore della Carità

Novara, Piedmont, 28100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intracoronary administration of an abciximab bolus during primary PCI

Drug

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

Intravenous administration of an abciximab bolus during primary PCI

Drug

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

Primary outcomes

  1. Change in C-reactive protein levels from baseline after PCI

    Time frame: 48h

    C-reactive protein will be evaluated at admission and 48 hours after the primary PCI as marker of the inflammatory reaction

Secondary outcomes

  1. Overall Mortality

    Time frame: 1year

    Mortality for all causes at 1year after primary PCI

  2. Target vessel revascularization

    Time frame: 1 year

    Target vessel revascularization at 1 year after primary PCI

  3. Myocardial infarction

    Time frame: 1 year

    Recurrent Myocardial infarction 1 year after PCI

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 31, 2012
Registry last updated
Dec 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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