FATA: Randomized Study on Facilitated Angioplasty With Tirofiban or Abciximab

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bologna
• Treatments: Abciximab; Antibodies, Monoclonal; Immunoglobulin Fab Fragments; Tirofiban

Criteria

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.