Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00383136
Status:
COMPLETED
Last Update Posted:
2008-01-16
First Post:
2006-09-29
Brief Title:
FATA Randomized Study on Facilitated Angioplasty With Tirofiban or Abciximab
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
FATA Comparison Between Tirofiban and Abciximab in Facilitated Angioplasty With Stent Implantation Randomized Multicentre Study
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FATA
Brief Summary:
The electivestandard 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 IIbIIIa platelet receptor
Tirofiban is another potent inhibitor of GP IIbIIIa platelet receptor with an efficacy on platelet aggregation inhibition equal to or greater than Abciximab if a high dose bolus is used ie 25 microgkg 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
Tirofiban is another potent inhibitor of GP IIbIIIa platelet receptor with an efficacy on platelet aggregation inhibition equal to or greater than Abciximab if a high dose bolus is used ie 25 microgkg 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
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 IIbIIIa 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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None