Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention
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ClinicalTrials.gov Identifier: NCT01757457 |
Recruitment Status
:
Completed
First Posted
: December 31, 2012
Last Update Posted
: December 31, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Infarction | Drug: Intracoronary administration of an abciximab bolus during primary PCI Drug: Intravenous administration of an abciximab bolus during primary PCI | Phase 4 |
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 (Clinical Trial) |
Actual Enrollment : | 89 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention.(Molecole di Adesione Nella Sindrome Coronarica Acuta |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | April 2008 |
Actual Study Completion Date : | April 2008 |

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
|
- 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
- Overall Mortality [ Time Frame: 1year ]Mortality for all causes at 1year after primary PCI
- Target vessel revascularization [ Time Frame: 1 year ]Target vessel revascularization at 1 year after primary PCI
- Myocardial infarction [ Time Frame: 1 year ]Recurrent Myocardial infarction 1 year after PCI

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757457
Italy | |
Ospedale Maggiore della Carità | |
Novara, Piedmont, Italy, 28100 |
Principal Investigator: | Alessandro Lupi, MD | AO Maggiore della Carita |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Lupi Alessandro, Principal Investigator, Azienda Ospedaliero Universitaria Maggiore della Carita |
ClinicalTrials.gov Identifier: | NCT01757457 History of Changes |
Other Study ID Numbers: |
0000004 |
First Posted: | December 31, 2012 Key Record Dates |
Last Update Posted: | December 31, 2012 |
Last Verified: | December 2012 |
Keywords provided by Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita:
inflammation thrombosis platelets adhesion molecules endothelium |
Additional relevant MeSH terms:
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
Anti-Inflammatory Agents Abciximab Antibodies, Monoclonal Immunoglobulin Fab Fragments Anticoagulants Platelet Aggregation Inhibitors Immunologic Factors Physiological Effects of Drugs |