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

NCT01757457 | Completed Phase 4 DMC

• 1 other identifier: 0000004
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocardial Infarction

Keywords

inflammation; thrombosis; platelets; adhesion molecules; endothelium

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Overall Mortality

  1year

• Target vessel revascularization

  1 year

• Myocardial infarction

  1 year

Study Arms (2)

Intracoronary abciximab

EXPERIMENTAL

Intracoronary administration of an abciximab bolus during primary PCI

Drug: Intracoronary administration of an abciximab bolus during primary PCI

Intravenous abciximab

ACTIVE COMPARATOR

Intravenous standard administration of an abciximab bolus during primary PCI

Drug: Intravenous administration of an abciximab bolus during primary PCI

Interventions

Intracoronary administration of an abciximab bolus during primary PCI DRUG

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

Intracoronary abciximab

Intravenous administration of an abciximab bolus during primary PCI DRUG

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

Intravenous abciximab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

Ospedale Maggiore della Carità

Novara, Piedmont, 28100, Italy

Location

Related Publications (1)

• 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.

  PMID: 25022932 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Inflammation; Thrombosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Embolism and Thrombosis

Study Officials

• Alessandro Lupi, MD

  AO Maggiore della Carita

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 31, 2012
• Study Start: April 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: December 31, 2012

Record last verified: 2012-12

Locations

IT (1)