Myocardial InfarctionPhase 4NCT01757457
Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention
A Phase 4 study testing Intracoronary administration of an abciximab bolus during primary PCI and Intravenous administration of an abciximab bolus during primary PCI in people with Myocardial Infarction, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Intracoronary administration of an abciximab bolus during primary PCI and Intravenous administration of an abciximab bolus during primary PCI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2006to Apr 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention.(Molecole di Adesione Nella Sindrome Coronarica Acuta
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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- Intracoronary administration of an abciximab bolus during primary PCI, Intravenous administration of an abciximab bolus during primary PCI
- Keywords
- inflammation, thrombosis, platelets, adhesion molecules, endothelium
- Medical subject headings
- Myocardial Infarction, Inflammation, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary administration of an abciximab bolus during primary PCIDrug
Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI
Intravenous administration of an abciximab bolus during primary PCIDrug
Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI
| Study group | Role | What they receive |
|---|---|---|
| Intracoronary abciximab | Experimental | Intracoronary administration of an abciximab bolus during primary PCI Receives: Drug: Intracoronary administration of an abciximab bolus during primary PCI |
| Intravenous abciximab | Active comparator | Intravenous standard administration of an abciximab bolus during primary PCI Receives: Drug: Intravenous administration of an abciximab bolus during primary PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48h
Secondary outcomes (3)
Overall Mortality
Mortality for all causes at 1year after primary PCI
Measured: 1year
Target vessel revascularization
Target vessel revascularization at 1 year after primary PCI
Measured: 1 year
Myocardial infarction
Recurrent Myocardial infarction 1 year after PCI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startApr 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Alessandro Lupi, MD, Principal investigator, AO Maggiore della Carita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757457
- Sponsor's protocol ID
- 0000004
- Status last verified
- Dec 2012
- First submitted
- 19 Dec 2012
- Last updated
- 31 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25022932
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention.(Molecole di Adesione Nella Sindrome Coronarica Acuta
- ClinicalTrials.gov ID
- NCT01757457
- Acronym / sponsor ID
- 0000004
- Conditions
- Myocardial Infarction
- Keywords
- inflammation, thrombosis, platelets, adhesion molecules, endothelium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 31 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracoronary abciximab | Experimental | Drug: Intracoronary administration of an abciximab bolus during primary PCIIntracoronary administration of an abciximab bolus during primary PCI |
| Intravenous abciximab | Active comparator | Drug: Intravenous administration of an abciximab bolus during primary PCIIntravenous standard administration of an abciximab bolus during primary PCI |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- age > 90 years;
- cardiogenic shock at admission;
- left main as IRA;
- saphenous vein graft as IRA;
- previous PCI in the last 6 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracoronary administration of an abciximab bolus during primary PCIIntracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI | Drug | Intracoronary abciximab |
| Intravenous administration of an abciximab bolus during primary PCIIntracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI | Drug | Intravenous abciximab |
Primary outcome
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
3 secondary outcomes
Overall Mortality
Time frame: 1year
Target vessel revascularization
Time frame: 1 year
Myocardial infarction
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2012.
- Derived from this study: PubMed 25022932Secco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Lupi, MD principal investigator
AO Maggiore della Carita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intracoronary administration of an abciximab bolus during primary PCI and Intravenous administration of an abciximab bolus during primary PCI in people with Myocardial Infarction, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in C-reactive protein levels from baseline after PCI (time frame: 48h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01757457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2012.