Acute Myocardial InfarctionPhase 4FATANCT00383136
FATA: Randomized Study on Facilitated Angioplasty With Tirofiban or Abciximab
A Phase 4 study testing tirofiban high-bolus dose regimen and Abciximab in people with Acute Myocardial Infarction, run by University of Bologna at 6 sites in Italy.
Trial summary
The elective("standard of care") treatment of ST - elevation acute myocardial infarction (STEMI) currently consists of primary angioplasty with stent implantation during administration of Abciximab, a inhibitor of GP IIb/IIIa platelet receptor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- tirofiban high-bolus dose regimen and Abciximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 692 participants
- Where
- 6 sitesItaly
- Study dates
- Jun 2003to Sep 2007
- 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
- STEMI diagnosed due to the presence of chest pain lasting at least 20 minutes and less than 6 hours, associated with elevation of the ST segment >1 mm in at least 2 adjacent leads
- Informed consent
- Age > 18 years
Who cannot join
- Complete left bundle branch block
- Previous myocardial infarction at the same site
- Post-anoxic coma
- Known thrombocytopenia or leucopenia
- Severe hepatic dysfunction;
- Previous episodes of hemorrhagic diathesis or allergy to ASA or thienopyridine;
Show all 18Show fewer
- Recent major surgery (< 3 months before)
- Associated diseases that involve short life expectancy (< 2 years);
- Arterial hypertension (AP >180/110);
- Positive case history for stroke within the previous 30 days;
- Positive case history for intracranial disease (aneurysm, arterovenous malformation);
- Major trauma within the previous six weeks;
- A clinical condition which, in the doctor's opinion, could interfere with the patient's full participation in the study;
- Pregnancy or fertile age;
- Anticoagulant therapy with dicumarol with INR > 2;
- Renal insufficiency (creatinine > 3.0 mg/dl) known at the time of the study;
- Previous treatment with thrombolytics (within the previous 48 hours);
- Participation in other studies in progress.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Divisione Di Cardiologia, Ospedale Maggiore
Bologna, BO, 40100
Laboratorio Di Emodinamica, Istituto Di Cardiologia, Azienda Ospedaliera S.Orsola Malpighi
Bologna, BO, 40138
Azienda Ospedaliera Universitaria Policlinico
Modena, MO, 41100
Divisione Di Cardiologia, Ospedale S.Maria Nuova
Reggio Emilia, RE, 42100
Divisione Di Cardiologia, Ospedale Per Gli Infermi
Rimini, RN, 47900
Divisione Di Cardiologia Ii, Ospedale Policlinico Le Molinette
Torino, TO, 10100
About this study
Official title: FATA: Comparison Between Tirofiban and Abciximab in Facilitated Angioplasty With Stent Implantation: Randomized Multicentre Study
The elective("standard of care") treatment of ST - elevation acute myocardial infarction (STEMI) currently consists of primary angioplasty with stent implantation during administration of Abciximab, a inhibitor of GP IIb/IIIa platelet receptor.
Tirofiban is another potent inhibitor of GP IIb/IIIa platelet receptor with an efficacy on platelet aggregation inhibition equal to or greater than Abciximab if a high dose bolus is used, i.e. 25 microg/kg, (platelet aggregation inhibition > 90% 15 minutes after infusion). It can therefore be hypothesized that this drug can improve the results of primary angioplasty to the same extent as Abciximab.
Read more
The aim of this study is to compare the efficacy, in terms of myocardial reperfusion indices, of Abciximab and high dose of Tirofiban in primary angioplasty for STEMI, both in the case of treatment before transfer and of treatment in the catheterization laboratory during the procedure.
The reference hypothesis for the study objective is the equivalence or the non-inferiority of Tirofiban with respect to Abciximab.
Read the detailed description
The Facilitated Angioplasty with Tirofiban or Abciximab Study (FATA Study) is a prospective multicentre study, randomized in 2 groups (high dose Tirofiban or Abciximab), on a sample of 700 patients with acute myocardial infarction for whom primary angioplasty is indicated. Patients will be enrolled in the Emergency Room or in the Intensive Care Unit and other hospital departments or externally in the event of intervention by the Emergency Ambulance Service 118. For all these patients it must be possible to administer a IIb/IIIa inhibitor immediately after ECG and clinical diagnosis, before transfer to the cath lab for the primary angioplasty procedure. Patients arriving directly in the cath lab without being randomized before transfer will also be included.
Major exclusion criteria are: Complete left bundle branch block, Previous myocardial infarction at the same site, Post-anoxic coma, Known thrombocytopenia or leucopenia, Previous episodes of hemorrhagic diathesis or allergy to ASA or thienopyridine; Anticoagulant therapy with dicumarol with INR > 2; Previous treatment with thrombolytics (within the previous 48 hours).
Randomization will take place as soon as possible after the diagnostic ECG and will be performed by means of a centralized automatic system using SMS messages sent by ordinary cell phones.
The primary endpoint is ST resolution 90 minutes after opening of the affected vessel. Secondary endpoints include: Patency of the vessel at the first selective angiography, no reflow phenomenon during the procedure, TIMI 3 flow at the end of the procedure, MACE (death, reinfarction*, urgent TVR°) at 30 days, MACE (death, reinfarction*, TVR°) at 6 months, major bleeding requiring transfusion or surgery, or a reduction in Hb of more than 5 g%, Ictus and intracranial hemorrhage.
To demonstrate the study hypothesis, i.e. that Tirofiban is equivalent to Abciximab in facilitating primary angioplasty in acute myocardial infarction, with sufficient statistical significance, the necessary number of patients for each drug was calculated on the basis of the methods used in equivalence studies and was fixed in 350 pts per group.
390 patients have been randomized (as of Sept 15th, 2006). Results are expected by the end of 2007.
This study will establish whether in primary angioplasty a high dose of Tirofiban has an equivalent effect to Abciximab, first in terms of microcirculation protection and then of long-term clinical results. If this hypothesis is confirmed, Tirofiban could be used as an alternative to Abciximab, with considerable savings given its much lower cost.
- Conditions
- Acute Myocardial Infarction
- Being tested
- tirofiban high-bolus dose regimen, Abciximab
- Keywords
- STEMI, Primary Angioplasty, Abciximab, Tirofiban
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tirofiban high-bolus dose regimenDrug
Also called Aggrastat
bolus of 25 mcg/kg of body weight, followed by 18 hours infusion of 0.15 mcg/kg/min.
AbciximabDrug
Also called Reopro
bolus of 0.25 mg/kg of body weight, followed by 12 hours infusion of 0.125 mcg/kg per minute
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tirofiban Receives: Drug: tirofiban high-bolus dose regimen |
| 2 | Active comparator | Abciximab Receives: Drug: Abciximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ST resolution
Measured: 90 minutes after opening of the IRA
Secondary outcomes (11)
Patency of the IRA
Measured: at the first selective angiography
No reflow
Measured: during the procedure
TIMI 3 flow
Measured: at the end of the procedure
Myocardial blush grade
Measured: at the end of the procedure
Contractile recovery assessed with total FE and WMSI measured by echocardiography
Measured: at 48 hours and 30 days
MACE (death, reinfarction*, urgent TVR)
Measured: at 30 days
MACE (death, reinfarction*, TVR)
Measured: One year
Major bleeding requiring transfusion or surgery, or a reduction in Hb of more than 5 g%.
Measured: in-hospital
Intracranial hemorrhage.
Measured: in-hospital
Symptoms associated with new ECG alterations and a new increase in myocardial enzymes
Measured: in-hospital
Need for a new PTCA or CABG
Measured: In-hospital, 30 days, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2006 (estimated)
- Study startJun 2003
- Primary completionSep 2007
- Study completionSep 2007
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 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
- 692 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Investigators
- ANTONIO MARZOCCHI, MD, Principal investigator, ISTITUTO DI CARDIOLOGIA, AZIENDA OSPEDALIERA S.ORSOLA-MALPIGHI, BOLOGNA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383136
- Sponsor's protocol ID
- FATA
- Acronym
- FATA
- Status last verified
- Jan 2008
- First submitted
- 29 Sep 2006
- Last updated
- 16 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marzocchi A, Manari A, Piovaccari G, Marrozzini C, Marra S, Magnavacchi P, Sangiorgio P, Marinucci L, Taglieri N, Gordini G, Binetti N, Guiducci V, Franco N, Reggiani ML, Saia F; FATA Investigators. Randomized comparison between tirofiban and abciximab to promote complete ST-resolution in primary angioplasty: results of the facilitated angioplasty with tirofiban or abciximab (FATA) in ST-elevation myocardial infarction trial. Eur Heart J. 2008 Dec;29(24):2972-80. doi: 10.1093/eurheartj/ehn467. Epub 2008 Oct 21.
PubMed 18940887
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FATA: Comparison Between Tirofiban and Abciximab in Facilitated Angioplasty With Stent Implantation: Randomized Multicentre Study
- ClinicalTrials.gov ID
- NCT00383136
- Acronym / sponsor ID
- FATA / FATA
- Conditions
- Acute Myocardial Infarction
- Keywords
- STEMI, Primary Angioplasty, Abciximab, Tirofiban
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 692 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 2 Oct 2006 (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.
The elective("standard of care") treatment of ST - elevation acute myocardial infarction (STEMI) currently consists of primary angioplasty with stent implantation during administration of Abciximab, a inhibitor of GP IIb/IIIa platelet receptor.
Tirofiban is another potent inhibitor of GP IIb/IIIa platelet receptor with an efficacy on platelet aggregation inhibition equal to or greater than Abciximab if a high dose bolus is used, i.e. 25 microg/kg, (platelet aggregation inhibition > 90% 15 minutes after infusion). It can therefore be hypothesized that this drug can improve the results of primary angioplasty to the same extent as Abciximab.
The aim of this study is to compare the efficacy, in terms of myocardial reperfusion indices, of Abciximab and high dose of Tirofiban in primary angioplasty for STEMI, both in the case of treatment before transfer and of treatment in the catheterization laboratory during the procedure.
The reference hypothesis for the study objective is the equivalence or the non-inferiority of Tirofiban with respect to Abciximab.
Detailed description
The Facilitated Angioplasty with Tirofiban or Abciximab Study (FATA Study) is a prospective multicentre study, randomized in 2 groups (high dose Tirofiban or Abciximab), on a sample of 700 patients with acute myocardial infarction for whom primary angioplasty is indicated. Patients will be enrolled in the Emergency Room or in the Intensive Care Unit and other hospital departments or externally in the event of intervention by the Emergency Ambulance Service 118. For all these patients it must be possible to administer a IIb/IIIa inhibitor immediately after ECG and clinical diagnosis, before transfer to the cath lab for the primary angioplasty procedure. Patients arriving directly in the cath lab without being randomized before transfer will also be included.
Major exclusion criteria are: Complete left bundle branch block, Previous myocardial infarction at the same site, Post-anoxic coma, Known thrombocytopenia or leucopenia, Previous episodes of hemorrhagic diathesis or allergy to ASA or thienopyridine; Anticoagulant therapy with dicumarol with INR > 2; Previous treatment with thrombolytics (within the previous 48 hours).
Randomization will take place as soon as possible after the diagnostic ECG and will be performed by means of a centralized automatic system using SMS messages sent by ordinary cell phones.
The primary endpoint is ST resolution 90 minutes after opening of the affected vessel. Secondary endpoints include: Patency of the vessel at the first selective angiography, no reflow phenomenon during the procedure, TIMI 3 flow at the end of the procedure, MACE (death, reinfarction*, urgent TVR°) at 30 days, MACE (death, reinfarction*, TVR°) at 6 months, major bleeding requiring transfusion or surgery, or a reduction in Hb of more than 5 g%, Ictus and intracranial hemorrhage.
To demonstrate the study hypothesis, i.e. that Tirofiban is equivalent to Abciximab in facilitating primary angioplasty in acute myocardial infarction, with sufficient statistical significance, the necessary number of patients for each drug was calculated on the basis of the methods used in equivalence studies and was fixed in 350 pts per group.
390 patients have been randomized (as of Sept 15th, 2006). Results are expected by the end of 2007.
This study will establish whether in primary angioplasty a high dose of Tirofiban has an equivalent effect to Abciximab, first in terms of microcirculation protection and then of long-term clinical results. If this hypothesis is confirmed, Tirofiban could be used as an alternative to Abciximab, with considerable savings given its much lower cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tirofiban high-bolus dose regimenTirofiban |
| 2 | Active comparator | Drug: AbciximabAbciximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- STEMI diagnosed due to the presence of chest pain lasting at least 20 minutes and less than 6 hours, associated with elevation of the ST segment >1 mm in at least 2 adjacent leads
- Informed consent
- Age > 18 years
Key exclusion criteria (18 listed)
- Complete left bundle branch block
- Previous myocardial infarction at the same site
- Post-anoxic coma
- Known thrombocytopenia or leucopenia
- Severe hepatic dysfunction;
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 |
|---|---|---|
| tirofiban high-bolus dose regimenAlso: Aggrastatbolus of 25 mcg/kg of body weight, followed by 18 hours infusion of 0.15 mcg/kg/min. | Drug | 1 |
| AbciximabAlso: Reoprobolus of 0.25 mg/kg of body weight, followed by 12 hours infusion of 0.125 mcg/kg per minute | Drug | 2 |
Primary outcome
ST resolution
Time frame: 90 minutes after opening of the IRA
11 secondary outcomes
Patency of the IRA
Time frame: at the first selective angiography
No reflow
Time frame: during the procedure
TIMI 3 flow
Time frame: at the end of the procedure
Myocardial blush grade
Time frame: at the end of the procedure
Contractile recovery assessed with total FE and WMSI measured by echocardiography
Time frame: at 48 hours and 30 days
MACE (death, reinfarction*, urgent TVR)
Time frame: at 30 days
MACE (death, reinfarction*, TVR)
Time frame: One year
Major bleeding requiring transfusion or surgery, or a reduction in Hb of more than 5 g%.
Time frame: in-hospital
Intracranial hemorrhage.
Time frame: in-hospital
Symptoms associated with new ECG alterations and a new increase in myocardial enzymes
Time frame: in-hospital
Need for a new PTCA or CABG
Time frame: In-hospital, 30 days, one 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 16 Jan 2008.
- Derived from this study: PubMed 18940887Marzocchi A, Manari A, Piovaccari G, Marrozzini C, Marra S, Magnavacchi P, Sangiorgio P, Marinucci L, Taglieri N, Gordini G, Binetti N, Guiducci V, Franco N, Reggiani ML, Saia F; FATA Investigators. Randomized comparison between tirofiban and abciximab to promote complete ST-resolution in primary angioplasty: results of the facilitated angioplasty with tirofiban or abciximab (FATA) in ST-elevation myocardial infarction trial. Eur Heart J. 2008 Dec;29(24):2972-80. doi: 10.1093/eurheartj/ehn467. Epub 2008 Oct 21.
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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.
ANTONIO MARZOCCHI, MD principal investigator
ISTITUTO DI CARDIOLOGIA, AZIENDA OSPEDALIERA S.ORSOLA-MALPIGHI, BOLOGNA
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tirofiban high-bolus dose regimen and Abciximab in people with Acute Myocardial Infarction, run by University of Bologna at 6 sites 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 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 16 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
ST resolution (time frame: 90 minutes after opening of the IRA). 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 NCT00383136, 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 16 Jan 2008; AzTrials last refreshed its copy on 7 Nov 2026.