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

NCT ID: NCT01757457

Last Updated: 2012-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-04-30

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction

Keywords

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inflammation thrombosis platelets adhesion molecules endothelium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intracoronary abciximab

Intracoronary administration of an abciximab bolus during primary PCI

Group Type EXPERIMENTAL

Intracoronary administration of an abciximab bolus during primary PCI

Intervention Type DRUG

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

Intravenous abciximab

Intravenous standard administration of an abciximab bolus during primary PCI

Group Type ACTIVE_COMPARATOR

Intravenous administration of an abciximab bolus during primary PCI

Intervention Type DRUG

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

Interventions

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Intracoronary administration of an abciximab bolus during primary PCI

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

Intervention Type DRUG

Intravenous administration of an abciximab bolus during primary PCI

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role lead

Responsible Party

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Lupi Alessandro

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandro Lupi, MD

Role: PRINCIPAL_INVESTIGATOR

AO Maggiore della Carita

Locations

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Ospedale Maggiore della Carità

Novara, Piedmont, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 25022932 (View on PubMed)

Other Identifiers

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0000004

Identifier Type: -

Identifier Source: org_study_id