FATA: Randomized Study on Facilitated Angioplasty With Tirofiban or Abciximab

Acute Myocardial Infarction Clinical Trial

— FATA  

Official title:

FATA: Comparison Between Tirofiban and Abciximab in Facilitated Angioplasty With Stent Implantation: Randomized Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383136
• Other study ID #: FATA
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2006
• Last updated: January 11, 2008
• Start date: June 2003
• Est. completion date: September 2007

Study information

• Verified date: January 2008
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 692
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Italy	Divisione Di Cardiologia, Ospedale Maggiore	Bologna	BO
Italy	Laboratorio Di Emodinamica, Istituto Di Cardiologia, Azienda Ospedaliera S.Orsola Malpighi	Bologna	BO
Italy	Azienda Ospedaliera Universitaria Policlinico	Modena	MO
Italy	Divisione Di Cardiologia, Ospedale S.Maria Nuova	Reggio Emilia	RE
Italy	Divisione Di Cardiologia, Ospedale Per Gli Infermi	Rimini	RN
Italy	Divisione Di Cardiologia Ii, Ospedale Policlinico Le Molinette	Torino	TO

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ST resolution		90 minutes after opening of the IRA	No
Secondary	Patency of the IRA		at the first selective angiography	No
Secondary	No reflow		during the procedure	No
Secondary	TIMI 3 flow		at the end of the procedure	No
Secondary	Myocardial blush grade		at the end of the procedure	No
Secondary	Contractile recovery assessed with total FE and WMSI measured by echocardiography		at 48 hours and 30 days	No
Secondary	MACE (death, reinfarction*, urgent TVR)		at 30 days	No
Secondary	MACE (death, reinfarction*, TVR)		One year	No
Secondary	Major bleeding requiring transfusion or surgery, or a reduction in Hb of more than 5 g%.		in-hospital	Yes
Secondary	Intracranial hemorrhage.		in-hospital	Yes
Secondary	Symptoms associated with new ECG alterations and a new increase in myocardial enzymes		in-hospital	No
Secondary	Need for a new PTCA or CABG		In-hospital, 30 days, one year	No