FATA: Randomized Study on Facilitated Angioplasty With Tirofiban or Abciximab

NCT00383136 | Completed Phase 4 DMC

• 1 other identifier: FATA
• Study Type: interventional
• Target: 692
• Locations: 1 country
• Sites: 6

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.

Conditions

Acute Myocardial Infarction

Keywords

STEMI; Primary Angioplasty; Abciximab; Tirofiban

Outcome Measures

Primary Outcomes (1)

• ST resolution

  90 minutes after opening of the IRA

Secondary Outcomes (11)

• Patency of the IRA

  at the first selective angiography

• No reflow

  during the procedure

• TIMI 3 flow

  at the end of the procedure

• Myocardial blush grade

  at the end of the procedure

• Contractile recovery assessed with total FE and WMSI measured by echocardiography

  at 48 hours and 30 days

Study Arms (2)

1

EXPERIMENTAL

Tirofiban

Drug: tirofiban high-bolus dose regimen

2

ACTIVE COMPARATOR

Abciximab

Drug: Abciximab

Interventions

tirofiban high-bolus dose regimen DRUG

bolus of 25 mcg/kg of body weight, followed by 18 hours infusion of 0.15 mcg/kg/min.

Also known as: Aggrastat

1

Abciximab DRUG

bolus of 0.25 mg/kg of body weight, followed by 12 hours infusion of 0.125 mcg/kg per minute

Also known as: Reopro

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (6)

Divisione Di Cardiologia, Ospedale Maggiore

Bologna, BO, 40100, Italy

Location

Laboratorio Di Emodinamica, Istituto Di Cardiologia, Azienda Ospedaliera S.Orsola Malpighi

Bologna, BO, 40138, Italy

Location

Azienda Ospedaliera Universitaria Policlinico

Modena, MO, 41100, Italy

Location

Divisione Di Cardiologia, Ospedale S.Maria Nuova

Reggio Emilia, RE, 42100, Italy

Location

Divisione Di Cardiologia, Ospedale Per Gli Infermi

Rimini, RN, 47900, Italy

Location

Divisione Di Cardiologia Ii, Ospedale Policlinico Le Molinette

Torino, TO, 10100, Italy

Location

Related Publications (1)

• 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.

  PMID: 18940887 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Tirofiban; Abciximab

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• ANTONIO MARZOCCHI, MD

  ISTITUTO DI CARDIOLOGIA, AZIENDA OSPEDALIERA S.ORSOLA-MALPIGHI, BOLOGNA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 2, 2006
• Study Start: June 1, 2003
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: January 16, 2008

Record last verified: 2008-01

Locations

IT (6)