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

Purpose

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.

Condition	Intervention	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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

Drug Information available for: Abciximab

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliero Universitaria Maggiore della Carita:

Primary Outcome Measures:

Change in C-reactive protein levels from baseline after PCI [ Time Frame: 48h ] [ Designated as safety issue: No ]
C-reactive protein will be evaluated at admission and 48 hours after the primary PCI as marker of the inflammatory reaction

Secondary Outcome Measures:

Overall Mortality [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
Mortality for all causes at 1year after primary PCI
Target vessel revascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Target vessel revascularization at 1 year after primary PCI
Myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Recurrent Myocardial infarction 1 year after PCI


Enrollment:	89
Study Start Date:	April 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757457

Locations


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

Sponsors and Collaborators

Azienda Ospedaliero Universitaria Maggiore della Carita

Investigators


Principal Investigator:	Alessandro Lupi, MD	AO Maggiore della Carita

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Lupi Alessandro, Principal Investigator, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier:	NCT01757457 History of Changes
Other Study ID Numbers:	0000004
Study First Received:	December 19, 2012
Last Updated:	December 28, 2012
Health Authority:	Italy: National Institute of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on September 26, 2016