FATA: Randomized Study on Facilitated Angioplasty With Tirofiban or Abciximab
Information source: University of Bologna
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myocardial Infarction
Intervention: tirofiban high-bolus dose regimen (Drug); Abciximab (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Bologna Official(s) and/or principal investigator(s): ANTONIO MARZOCCHI, MD, Principal Investigator, Affiliation: ISTITUTO DI CARDIOLOGIA, AZIENDA OSPEDALIERA S.ORSOLA-MALPIGHI, BOLOGNA
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.
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.
Clinical Details
Official title: FATA: Comparison Between Tirofiban and Abciximab in Facilitated Angioplasty With Stent Implantation: Randomized Multicentre Study
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: ST resolution
Secondary outcome: Patency of the IRANo reflow TIMI 3 flow Myocardial blush grade Contractile recovery assessed with total FE and WMSI measured by echocardiography MACE (death, reinfarction*, urgent TVR) MACE (death, reinfarction*, TVR) Major bleeding requiring transfusion or surgery, or a reduction in Hb of more than 5 g%. Intracranial hemorrhage. Symptoms associated with new ECG alterations and a new increase in myocardial enzymes Need for a new PTCA or CABG
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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
2. Informed consent
3. Age > 18 years
Exclusion Criteria:
1. Complete left bundle branch block
2. Previous myocardial infarction at the same site
3. Post-anoxic coma
4. Known thrombocytopenia or leucopenia
5. Severe hepatic dysfunction;
6. Previous episodes of hemorrhagic diathesis or allergy to ASA or thienopyridine;
7. Recent major surgery (< 3 months before)
8. Associated diseases that involve short life expectancy (< 2 years);
9. Arterial hypertension (AP >180/110);
10. Positive case history for stroke within the previous 30 days;
11. Positive case history for intracranial disease (aneurysm, arterovenous malformation);
12. Major trauma within the previous six weeks;
13. A clinical condition which, in the doctor's opinion, could interfere with the
patient's full participation in the study;
14. Pregnancy or fertile age;
15. Anticoagulant therapy with dicumarol with INR > 2;
16. Renal insufficiency (creatinine > 3. 0 mg/dl) known at the time of the study;
17. Previous treatment with thrombolytics (within the previous 48 hours);
18. Participation in other studies in progress.
Locations and Contacts
Divisione Di Cardiologia, Ospedale Maggiore, Bologna, BO 40100, Italy
Laboratorio Di Emodinamica, Istituto Di Cardiologia, Azienda Ospedaliera S.Orsola Malpighi, Bologna, BO 40138, Italy
Azienda Ospedaliera Universitaria Policlinico, Modena, MO 41100, Italy
Divisione Di Cardiologia, Ospedale S.Maria Nuova, Reggio Emilia, RE 42100, Italy
Divisione Di Cardiologia, Ospedale Per Gli Infermi, Rimini, RN 47900, Italy
Divisione Di Cardiologia Ii, Ospedale Policlinico Le Molinette, Torino, TO 10100, Italy
Additional Information
Starting date: June 2003
Last updated: January 11, 2008
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