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FATA: Randomized Study on Facilitated Angioplasty With Tirofiban or Abciximab (FATA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00383136
Recruitment Status : Completed
First Posted : October 2, 2006
Last Update Posted : January 16, 2008
Information provided by:
University of Bologna

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: tirofiban high-bolus dose regimen Drug: Abciximab Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 692 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FATA: Comparison Between Tirofiban and Abciximab in Facilitated Angioplasty With Stent Implantation: Randomized Multicentre Study
Study Start Date : June 2003
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: tirofiban high-bolus dose regimen
bolus of 25 mcg/kg of body weight, followed by 18 hours infusion of 0.15 mcg/kg/min.
Other Name: Aggrastat

Active Comparator: 2
Drug: Abciximab
bolus of 0.25 mg/kg of body weight, followed by 12 hours infusion of 0.125 mcg/kg per minute
Other Name: Reopro

Primary Outcome Measures :
  1. ST resolution [ Time Frame: 90 minutes after opening of the IRA ]

Secondary Outcome Measures :
  1. Patency of the IRA [ Time Frame: at the first selective angiography ]
  2. No reflow [ Time Frame: during the procedure ]
  3. TIMI 3 flow [ Time Frame: at the end of the procedure ]
  4. Myocardial blush grade [ Time Frame: at the end of the procedure ]
  5. Contractile recovery assessed with total FE and WMSI measured by echocardiography [ Time Frame: at 48 hours and 30 days ]
  6. MACE (death, reinfarction*, urgent TVR) [ Time Frame: at 30 days ]
  7. MACE (death, reinfarction*, TVR) [ Time Frame: One year ]
  8. Major bleeding requiring transfusion or surgery, or a reduction in Hb of more than 5 g%. [ Time Frame: in-hospital ]
  9. Intracranial hemorrhage. [ Time Frame: in-hospital ]
  10. Symptoms associated with new ECG alterations and a new increase in myocardial enzymes [ Time Frame: in-hospital ]
  11. Need for a new PTCA or CABG [ Time Frame: In-hospital, 30 days, one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00383136

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Divisione Di Cardiologia, Ospedale Maggiore
Bologna, BO, Italy, 40100
Laboratorio Di Emodinamica, Istituto Di Cardiologia, Azienda Ospedaliera S.Orsola Malpighi
Bologna, BO, Italy, 40138
Azienda Ospedaliera Universitaria Policlinico
Modena, MO, Italy, 41100
Divisione Di Cardiologia, Ospedale S.Maria Nuova
Reggio Emilia, RE, Italy, 42100
Divisione Di Cardiologia, Ospedale Per Gli Infermi
Rimini, RN, Italy, 47900
Divisione Di Cardiologia Ii, Ospedale Policlinico Le Molinette
Torino, TO, Italy, 10100
Sponsors and Collaborators
University of Bologna
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Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Antonio Marzocchi M.D., Istituto di Cardiologia, University of Bologna Identifier: NCT00383136    
Other Study ID Numbers: FATA
First Posted: October 2, 2006    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: January 2008
Keywords provided by University of Bologna:
Primary Angioplasty
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action