Acute Coronary SyndromePhase 4FABOLUSNCT00929279
Efficacy of Abciximab Bolus Only Regimen in Providing Inhibition of Platelet Action Over Time
A Phase 4 study testing bolus+infusion and abciximab bolus only regimen in people with Acute Coronary Syndrome, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
In full responders to clopidogrel scheduled to undergo PCI for NSTEACS, the use of abciximab bolus only plus 600 mg clopidogrel loading dose will result in a non-inferior inhibition of platelet aggregation after 4 hours as measured by LTA (20micromol ADP) when compared with abciximab plus infusion and 300 mg… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- bolus+infusion and abciximab bolus only regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2008to May 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both of the following:
- Age >18 years
- Symptoms of ischemia that were increasing or occurred at rest, with the last episode occurring no more than 24 hours before randomization;
- AND at least one of the following:
- An elevated cardiac troponin T level (≥0.015 μg per liter);
- The presence of ischemic changes as assessed by electrocardiography (defined as ST-segment depression or transient ST-segment elevation exceeding 0.05 mV, or T-wave inversion of ≥0.2 mV in two contiguous leads)
- A documented history of coronary artery disease as evidenced by previous myocardial infarction, findings on previous coronary angiography, or a positive exercise test.
Who cannot join
- The exclusion criteria are:
- administration of fibrinolytic or any GP IIb IIIa inhibitors for the treatment of current AMI or within 1 month before it
- history of bleeding diathesis
- known sensitivity to abciximab, to any component of the product or to murine monoclonal antibodies
- major surgery or trauma within 30 days
- active bleeding
Show all 18Show fewer
- previous stroke in the last six months
- oral anticoagulant therapy
- pre-existing thrombocytopenia;
- vasculitis;
- hypertensive retinopathy;
- severe hepatic failure,
- severe renal failure requiring haemodialysis
- documented allergy/intolerance or contraindication to clopidogrel or inability to assume clopidogrel on a consecutive daily basis for a minimum of 30 days, or to heparin or aspirin
- uncontrolled hypertension (systolic or diastolic arterial pressure >180 mmHg or 120, respectively, despite medical therapy)
- limited life expectancy, e.g. neoplasms, others
- inability to obtain informed consent
- pregnancy.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institue of Cardiology, University of Ferrara
Ferrara, Ferrara, 44100
About this study
Official title: Facilitation Through Abciximab By drOpping Infusion Line in Patients Undergoing Coronary Stenting. SYNergy With Clopidogrel at High Loading dOse Regimen
In full responders to clopidogrel scheduled to undergo PCI for NSTEACS, the use of abciximab bolus only plus 600 mg clopidogrel loading dose will result in a non-inferior inhibition of platelet aggregation after 4 hours as measured by LTA (20micromol ADP) when compared with abciximab plus infusion and 300 mg clopidogrel loading dose.
Read the detailed description
Based on the outcome of the EPIC trial, and the sub-optimal results with a single abciximab bolus compared with bolus and infusion, it was recommended to prolong platelet inhibition by a 12h infusion of abciximab after the initial bolus administration in patients undergoing percutaneous coronary intervention (PCI). However, lower outcomes in the single bolus group in the EPIC study were entirely driven by the rates of urgent repeat revascularization at 30 days (3•6 percent bolus group versus 0•8 percent bolus and infusion group, p < 0.001), a complication probably related to the lack of stent use at that time. Importantly, there was no significant difference in terms of death or myocardial infarction (MI). Moreover, the use of clopidogrel in patients undergoing coronary stenting may currently reduce the need for infusion after a single abciximab bolus and it is likely that the soon to come availably of even more potent oral thienopyridines with faster onset of action such as prasugrel may further contribute to make post-bolus abciximab infusion of marginal clinical benefit. Yet, it is known that infusion, as compared to bolus only regimen increases the bleeding rate and the incidence of thrombocytopenia. Thus, bolus only regimen has the potential to maintain protection from ischemic complications in patients undergoing PCI while optimizing the safety profile of the treatment in the current era of intervention based on stents and thienopyridines with fast onset of action.
The CLEAR-PLATELETS study has recently shown that 600 mg clopidogrel does not affect the degree of platelet inhibition throughout infusion of eptifibatide, which is consistent with the notion that glycoprotein IIb/IIIa inhibition at steady state leads to near maximal platelet blockade. No study has so far investigated the effect of clopidogrel, given at high loading dose, in patients treated with abciximab bolus only. In particular, it is not known whether the administration of clopidogrel at high loading dose may prolong the effect of abciximab bolus on the degree of platelet inhibition and if so at which time point the combination of abciximab bolus and clopidogrel may become suboptimal in terms of platelet inhibition as compared to currently recommended 12h infusion of abciximab after the initial bolus administration. This information would lead to relevant clinical implications as it may define the time frame for a safe and effective intervention after bolus only of abciximab in current practice.
This is a single-centre, double-blind prospective randomized pharmacodynamic investigation of 2 antiplatelet regimens in patients undergoing coronary stenting for non-ST segment elevation acute coronary syndromes (NSTECACS):
- Abciximab bolus followed by infusion plus on-label clopidogrel administration at 300 mg loading dose.
- abciximab bolus without infusion plus high loading dose of clopidogrel at 600 mg
The objective of the investigation is to test the hypothesis that the administration of abciximab bolus only plus high loading dose of clopidogrel at 600 mg will provide a non inferior level of inhibition of platelet aggregation 4 hours after administration as compared to abciximab bolus followed by standard infusion in combination with clopidogrel loading dose of 300 mg in patients with normal response to clopidogrel (as evaluated after 14-30 days).
- Conditions
- Acute Coronary Syndrome
- Being tested
- bolus+infusion, abciximab bolus only regimen
- Keywords
- Acute coronary syndrome, Abciximab, Bolus, Infusion, platelet inhibition, Non ST segment elevation acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bolus+infusionDrug
Abciximab bolus of 0.25mg /Kg, followed by a 12-h infusion 0.125 microg/Kg/min (to a maximum of 10 µg/min) and immediate clopidogrel at 300 mg loading regimen
abciximab bolus only regimenDrug
Abciximab bolus of 0.25mg /Kg followed by placebo infusion and immediate clopidogrel at 600 mg loading dose
| Study group | Role | What they receive |
|---|---|---|
| Abciximab bolus plus infusion | Active comparator | Abciximab bolus of 0.25mg /Kg, followed by a 12-h infusion 0.125 microg/Kg/min (to a maximum of 10 µg/min) and immediate clopidogrel at 300 mg loading regimen. Receives: Drug: bolus+infusion |
| bolus only regimen | Experimental | Abciximab bolus of 0.25mg /Kg followed by placebo infusion and immediate clopidogrel at 600 mg loading dose Receives: Drug: abciximab bolus only regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
In responders to clopidogrel: Inhibition of platelet aggregation at peak 4h after administration of study drugs measured by LTA (stimulated with 20micromolar ADP)
Measured: 4 hours
Secondary outcomes (4)
In all patients treated and in the responders to clopidogrel: • Inhibition of platelet aggregation in the two study groups at time points different from 4 hours after abciximab bolus measured by LTA
Measured: up to 24 hours
MACE rate
Measured: 30 days
Bleeding rates
Measured: 30 days
Thrombocytopenia
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startNov 2008
- Primary completionMay 2009
- Study completionMay 2009
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 Acute Coronary SyndromeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929279
- Sponsor's protocol ID
- FAS-07-I
- Acronym
- FABOLUS
- Status last verified
- Jun 2009
- First submitted
- 26 Jun 2009
- Last updated
- 29 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Valgimigli M, Campo G, Tebaldi M, Monti M, Gambetti S, Scalone A, Parrinello G, Ferrari R; Fabolus Synchro (facilitation through abciximab by dropping infusion Line in patients undergoing coronary stenting. Synergy with clopidogrel at high loading dose regimen) Investigators. Randomized, double-blind comparison of effects of abiciximab bolus only vs. on-label regimen on ex vivo inhibition of platelet aggregation in responders to clopidogrel undergoing coronary stenting. J Thromb Haemost. 2010 Sep;8(9):1903-11. doi: 10.1111/j.1538-7836.2010.03972.x.
PubMed 20586923
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitation Through Abciximab By drOpping Infusion Line in Patients Undergoing Coronary Stenting. SYNergy With Clopidogrel at High Loading dOse Regimen
- ClinicalTrials.gov ID
- NCT00929279
- Acronym / sponsor ID
- FABOLUS / FAS-07-I
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, Abciximab, Bolus, Infusion, platelet inhibition, Non ST segment elevation acute coronary syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 29 Jun 2009 (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.
In full responders to clopidogrel scheduled to undergo PCI for NSTEACS, the use of abciximab bolus only plus 600 mg clopidogrel loading dose will result in a non-inferior inhibition of platelet aggregation after 4 hours as measured by LTA (20micromol ADP) when compared with abciximab plus infusion and 300 mg clopidogrel loading dose.
Detailed description
Based on the outcome of the EPIC trial, and the sub-optimal results with a single abciximab bolus compared with bolus and infusion, it was recommended to prolong platelet inhibition by a 12h infusion of abciximab after the initial bolus administration in patients undergoing percutaneous coronary intervention (PCI). However, lower outcomes in the single bolus group in the EPIC study were entirely driven by the rates of urgent repeat revascularization at 30 days (3•6 percent bolus group versus 0•8 percent bolus and infusion group, p < 0.001), a complication probably related to the lack of stent use at that time. Importantly, there was no significant difference in terms of death or myocardial infarction (MI). Moreover, the use of clopidogrel in patients undergoing coronary stenting may currently reduce the need for infusion after a single abciximab bolus and it is likely that the soon to come availably of even more potent oral thienopyridines with faster onset of action such as prasugrel may further contribute to make post-bolus abciximab infusion of marginal clinical benefit. Yet, it is known that infusion, as compared to bolus only regimen increases the bleeding rate and the incidence of thrombocytopenia. Thus, bolus only regimen has the potential to maintain protection from ischemic complications in patients undergoing PCI while optimizing the safety profile of the treatment in the current era of intervention based on stents and thienopyridines with fast onset of action.
The CLEAR-PLATELETS study has recently shown that 600 mg clopidogrel does not affect the degree of platelet inhibition throughout infusion of eptifibatide, which is consistent with the notion that glycoprotein IIb/IIIa inhibition at steady state leads to near maximal platelet blockade. No study has so far investigated the effect of clopidogrel, given at high loading dose, in patients treated with abciximab bolus only. In particular, it is not known whether the administration of clopidogrel at high loading dose may prolong the effect of abciximab bolus on the degree of platelet inhibition and if so at which time point the combination of abciximab bolus and clopidogrel may become suboptimal in terms of platelet inhibition as compared to currently recommended 12h infusion of abciximab after the initial bolus administration. This information would lead to relevant clinical implications as it may define the time frame for a safe and effective intervention after bolus only of abciximab in current practice.
This is a single-centre, double-blind prospective randomized pharmacodynamic investigation of 2 antiplatelet regimens in patients undergoing coronary stenting for non-ST segment elevation acute coronary syndromes (NSTECACS):
- Abciximab bolus followed by infusion plus on-label clopidogrel administration at 300 mg loading dose.
- abciximab bolus without infusion plus high loading dose of clopidogrel at 600 mg
The objective of the investigation is to test the hypothesis that the administration of abciximab bolus only plus high loading dose of clopidogrel at 600 mg will provide a non inferior level of inhibition of platelet aggregation 4 hours after administration as compared to abciximab bolus followed by standard infusion in combination with clopidogrel loading dose of 300 mg in patients with normal response to clopidogrel (as evaluated after 14-30 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abciximab bolus plus infusion | Active comparator | Drug: bolus+infusionAbciximab bolus of 0.25mg /Kg, followed by a 12-h infusion 0.125 microg/Kg/min (to a maximum of 10 µg/min) and immediate clopidogrel at 300 mg loading regimen. |
| bolus only regimen | Experimental | Drug: abciximab bolus only regimenAbciximab bolus of 0.25mg /Kg followed by placebo infusion and immediate clopidogrel at 600 mg loading dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years
- Symptoms of ischemia that were increasing or occurred at rest, with the last episode occurring no more than 24 hours before randomization;
- An elevated cardiac troponin T level (≥0.015 μg per liter);
- The presence of ischemic changes as assessed by electrocardiography (defined as ST-segment depression or transient ST-segment elevation exceeding 0.05 mV, or T-wave inversion of ≥0.2 mV in two contiguous leads)
- A documented history of coronary artery disease as evidenced by previous myocardial infarction, findings on previous coronary angiography, or a positive exercise test.
Key exclusion criteria (18 listed)
- The exclusion criteria are:
- administration of fibrinolytic or any GP IIb IIIa inhibitors for the treatment of current AMI or within 1 month before it
- history of bleeding diathesis
- known sensitivity to abciximab, to any component of the product or to murine monoclonal antibodies
- major surgery or trauma within 30 days
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 |
|---|---|---|
| bolus+infusionAbciximab bolus of 0.25mg /Kg, followed by a 12-h infusion 0.125 microg/Kg/min (to a maximum of 10 µg/min) and immediate clopidogrel at 300 mg loading regimen | Drug | Abciximab bolus plus infusion |
| abciximab bolus only regimenAbciximab bolus of 0.25mg /Kg followed by placebo infusion and immediate clopidogrel at 600 mg loading dose | Drug | bolus only regimen |
Primary outcome
In responders to clopidogrel: Inhibition of platelet aggregation at peak 4h after administration of study drugs measured by LTA (stimulated with 20micromolar ADP)
Time frame: 4 hours
4 secondary outcomes
In all patients treated and in the responders to clopidogrel: • Inhibition of platelet aggregation in the two study groups at time points different from 4 hours after abciximab bolus measured by LTA
Time frame: up to 24 hours
MACE rate
Time frame: 30 days
Bleeding rates
Time frame: 30 days
Thrombocytopenia
Time frame: 30 days
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 29 Jun 2009.
- Derived from this study: PubMed 20586923Valgimigli M, Campo G, Tebaldi M, Monti M, Gambetti S, Scalone A, Parrinello G, Ferrari R; Fabolus Synchro (facilitation through abciximab by dropping infusion Line in patients undergoing coronary stenting. Synergy with clopidogrel at high loading dose regimen) Investigators. Randomized, double-blind comparison of effects of abiciximab bolus only vs. on-label regimen on ex vivo inhibition of platelet aggregation in responders to clopidogrel undergoing coronary stenting. J Thromb Haemost. 2010 Sep;8(9):1903-11. doi: 10.1111/j.1538-7836.2010.03972.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 bolus+infusion and abciximab bolus only regimen in people with Acute Coronary Syndrome, run by Università degli Studi di Ferrara 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 7 inclusion and 18 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 29 Jun 2009. 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?
In responders to clopidogrel: Inhibition of platelet aggregation at peak 4h after administration of study drugs measured by LTA (stimulated with 20micromolar ADP) (time frame: 4 hours). 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 NCT00929279, 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 29 Jun 2009.