Status:
COMPLETED
FATA: Randomized Study on Facilitated Angioplasty With Tirofiban or Abciximab
Lead Sponsor:
University of Bologna
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
692 Patients enrolled
Trial Details
Trial ID
NCT00383136
Start Date
June 1 2003
End Date
September 1 2007
Last Update
January 16 2008
Active Locations (6)
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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