A Phase 4 interventional study of tirofiban high-bolus dose regimen and Abciximab in Acute Myocardial Infarction, sponsored by University of Bologna. Completed at 6 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-16.
Sponsored by University of Bologna · Phase 4, Interventional, and Treatment
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.
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 692 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →University of Bologna is the lead sponsor of 153 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tirofiban
Drug: tirofiban high-bolus dose regimen
Abciximab
Drug: Abciximab
bolus of 25 mcg/kg of body weight, followed by 18 hours infusion of 0.15 mcg/kg/min.
Also known as: Aggrastat
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
ST resolution
Time frame: 90 minutes after opening of the IRA
Patency of the IRA
Time frame: at the first selective angiography
No reflow
Time frame: during the procedure
TIMI 3 flow
Time frame: at the end of the procedure
Myocardial blush grade
Time frame: at the end of the procedure
Contractile recovery assessed with total FE and WMSI measured by echocardiography
Time frame: at 48 hours and 30 days
MACE (death, reinfarction*, urgent TVR)
Time frame: at 30 days
MACE (death, reinfarction*, TVR)
Time frame: One year
Major bleeding requiring transfusion or surgery, or a reduction in Hb of more than 5 g%.
Time frame: in-hospital
Intracranial hemorrhage.
Time frame: in-hospital
Symptoms associated with new ECG alterations and a new increase in myocardial enzymes
Time frame: in-hospital
Need for a new PTCA or CABG
Time frame: In-hospital, 30 days, one year
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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University of Bologna