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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Intracoronary administration of an abciximab bolus during primary PCI
Intravenous administration of an abciximab bolus during primary PCI
Sponsored by
Azienda Ospedaliero Universitaria Maggiore della Carita
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring inflammation, thrombosis, platelets, adhesion molecules, endothelium

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ospedale Maggiore della Carità

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intracoronary abciximab

Intravenous abciximab

Arm Description

Intracoronary administration of an abciximab bolus during primary PCI

Intravenous standard administration of an abciximab bolus during primary PCI

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Mortality
Mortality for all causes at 1year after primary PCI
Target vessel revascularization
Target vessel revascularization at 1 year after primary PCI
Myocardial infarction
Recurrent Myocardial infarction 1 year after PCI

Full Information

First Posted
December 19, 2012
Last Updated
December 28, 2012
Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
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1. Study Identification

Unique Protocol Identification Number
NCT01757457
Brief Title
Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention
Official Title
Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention.(Molecole di Adesione Nella Sindrome Coronarica Acuta
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
inflammation, thrombosis, platelets, adhesion molecules, endothelium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intracoronary abciximab
Arm Type
Experimental
Arm Description
Intracoronary administration of an abciximab bolus during primary PCI
Arm Title
Intravenous abciximab
Arm Type
Active Comparator
Arm Description
Intravenous standard administration of an abciximab bolus during primary PCI
Intervention Type
Drug
Intervention Name(s)
Intracoronary administration of an abciximab bolus during primary PCI
Intervention Description
Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI
Intervention Type
Drug
Intervention Name(s)
Intravenous administration of an abciximab bolus during primary PCI
Intervention Description
Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI
Primary Outcome Measure Information:
Title
Change in C-reactive protein levels from baseline after PCI
Description
C-reactive protein will be evaluated at admission and 48 hours after the primary PCI as marker of the inflammatory reaction
Time Frame
48h
Secondary Outcome Measure Information:
Title
Overall Mortality
Description
Mortality for all causes at 1year after primary PCI
Time Frame
1year
Title
Target vessel revascularization
Description
Target vessel revascularization at 1 year after primary PCI
Time Frame
1 year
Title
Myocardial infarction
Description
Recurrent Myocardial infarction 1 year after PCI
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Lupi, MD
Organizational Affiliation
AO Maggiore della Carita
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Maggiore della Carità
City
Novara
State/Province
Piedmont
ZIP/Postal Code
28100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25022932
Citation
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.
Results Reference
derived

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

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