FATA: Randomized Study on Facilitated Angioplasty With Tirofiban or Abciximab

Sponsor

University of Bologna (Other)

Overall Status

Completed

CT.gov ID

NCT00383136

Collaborator

(none)

692

Enrollment

Locations

Arms

Duration (Months)

115.3

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jun 1, 2003

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Tirofiban	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 Names: Aggrastat
Active Comparator: 2 Abciximab	Drug: Abciximab bolus of 0.25 mg/kg of body weight, followed by 12 hours infusion of 0.125 mcg/kg per minute Other Names: Reopro

Arm

Intervention/Treatment

Experimental: 1

Tirofiban

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 Names:

Aggrastat

Active Comparator: 2

Abciximab

Drug: Abciximab

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

Other Names:

Reopro

Outcome Measures

Primary Outcome Measures

ST resolution [90 minutes after opening of the IRA]

Secondary Outcome Measures

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]
MACE (death, reinfarction*, urgent TVR) [at 30 days]
MACE (death, reinfarction*, TVR) [One year]
Major bleeding requiring transfusion or surgery, or a reduction in Hb of more than 5 g%. [in-hospital]
Intracranial hemorrhage. [in-hospital]
Symptoms associated with new ECG alterations and a new increase in myocardial enzymes [in-hospital]
Need for a new PTCA or CABG [In-hospital, 30 days, one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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;
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Divisione Di Cardiologia, Ospedale Maggiore	Bologna	BO	Italy	40100
2	Laboratorio Di Emodinamica, Istituto Di Cardiologia, Azienda Ospedaliera S.Orsola Malpighi	Bologna	BO	Italy	40138
3	Azienda Ospedaliera Universitaria Policlinico	Modena	MO	Italy	41100
4	Divisione Di Cardiologia, Ospedale S.Maria Nuova	Reggio Emilia	RE	Italy	42100
5	Divisione Di Cardiologia, Ospedale Per Gli Infermi	Rimini	RN	Italy	47900
6	Divisione Di Cardiologia Ii, Ospedale Policlinico Le Molinette	Torino	TO	Italy	10100