Clinical trial NCT00244426: S.I.F.A. II: Prevention Of Thromboembolic Events In Patients With Nonrheumatic Atrial Fibrillation
Official title: II Italian Study on Atrial Fibrillation (S.I.F.A. II): Prevention of Thromboembolic Events in Patients With Non Valvular Atrial Fibrillation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Prevention of thromboembolic events in patients with non valvular atrial fibrillation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-26
Enrollment: 1372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate efficacy and safety of Indobufen v. Aspirin in preventing thromboembolic events in patients at high risk of CV events such as patients suffering from nonrheumatic atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Chronic or paroxysmal non rheumatic atrial fibrillation with cardioembolic risk factors: hypertension, ischemic cardiopathy, Congestive Heart Failure, diabetes mellitus

Exclusion Criteria:

* Clinically relevant organ disease
* creatinine clearance \< 30 ml/min
* gastric or duodenal ulcer
* severe anaemia or poliglobulia

Primary outcomes:
measure: combined endpoints: cerebral ictus (ischemic or haemorragic), cardiovascular death, nonfatal acute myocardial infarction (AMI) or peripheral embolism. The first event occurring during the study will be considered.
timeFrame: 3.5 years
Secondary outcomes:
measure: Global mortality, ischemic ictus, disabling ictus, TIA, nonfatal acute myocardial infarction, fatal and nonfatal hemorrhagic events, fatal and nonfatal embolisms.
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Lagosanto
country: Italy
facility: Pfizer Investigational Site
state: FE
city: Perugia
country: Italy
facility: Pfizer Investigational Site
state: PG
city: Perugia
country: Italy
facility: Pfizer Investigational Site
state: PG
city: Poggibonsi
country: Italy
facility: Pfizer Investigational Site
state: SI
city: Siena
country: Italy
facility: Pfizer Investigational Site
state: SI
city: Busto Arsizio
country: Italy
facility: Pfizer Investigational Site
state: VA
city: Peschiera Del Garda
country: Italy
facility: Pfizer Investigational Site
state: VR
city: Abbadia S. Salvatore (SI)
country: Italy
facility: Pfizer Investigational Site
city: Acquaviva Delle Fonti (BA)
country: Italy
facility: Pfizer Investigational Site
city: Albano Laziale
country: Italy
facility: Pfizer Investigational Site
city: Alessandria
country: Italy
facility: Pfizer Investigational Site
city: Ancona
country: Italy
facility: Pfizer Investigational Site
city: Ancona
country: Italy
facility: Pfizer Investigational Site
city: Angera
country: Italy
facility: Pfizer Investigational Site
city: Antella
country: Italy
facility: Pfizer Investigational Site
city: Aosta
country: Italy
facility: Pfizer Investigational Site
city: Arezzo
country: Italy
facility: Pfizer Investigational Site
city: Assisi
country: Italy
facility: Pfizer Investigational Site
city: Asti
country: Italy
facility: Pfizer Investigational Site
city: Avellino
country: Italy
facility: Pfizer Investigational Site
city: Bari
country: Italy
facility: Pfizer Investigational Site
city: Bari
country: Italy
facility: Pfizer Investigational Site
city: Bentivoglio
country: Italy
facility: Pfizer Investigational Site
city: Bergamo
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Brindisi
country: Italy
facility: Pfizer Investigational Site
city: Cagliari
country: Italy
facility: Pfizer Investigational Site
city: Carbonia
country: Italy
facility: Pfizer Investigational Site
city: Casarano (LE)
country: Italy
facility: Pfizer Investigational Site
city: Casarano
country: Italy
facility: Pfizer Investigational Site
city: Caserta
country: Italy
facility: Pfizer Investigational Site
city: Cassano Delle Murge (BA)
country: Italy
facility: Pfizer Investigational Site
city: Castelfranco Veneto
country: Italy
facility: Pfizer Investigational Site
city: Castiglion Del Lago
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Catanzaro
country: Italy
facility: Pfizer Investigational Site
city: Cesena
country: Italy
facility: Pfizer Investigational Site
city: Chieti
country: Italy
facility: Pfizer Investigational Site
city: Cirie (TO)
country: Italy
facility: Pfizer Investigational Site
city: Citta della Pieve
country: Italy
facility: Pfizer Investigational Site
city: Citta' Di Castello (Pg)
country: Italy
facility: Pfizer Investigational Site
city: Cittadella
country: Italy
facility: Pfizer Investigational Site
city: Copertino
country: Italy
facility: Pfizer Investigational Site
city: Cosenza
country: Italy
facility: Pfizer Investigational Site
city: Cremona
country: Italy
facility: Pfizer Investigational Site
city: Cuneo
country: Italy
facility: Pfizer Investigational Site
city: Desio
country: Italy
facility: Pfizer Investigational Site
city: Eboli (SA)
country: Italy
facility: Pfizer Investigational Site
city: Faenza
country: Italy
facility: Pfizer Investigational Site
city: Fidenza
country: Italy
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Foggia
country: Italy
facility: Pfizer Investigational Site
city: Foligno
country: Italy
facility: Pfizer Investigational Site
city: Forlimpopoli (Fo)
country: Italy
facility: Pfizer Investigational Site
city: Forli
country: Italy
facility: Pfizer Investigational Site
city: Frosinone
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Giulianova
country: Italy
facility: Pfizer Investigational Site
city: Gorizia
country: Italy
facility: Pfizer Investigational Site
city: Gracciano (Si)
country: Italy
facility: Pfizer Investigational Site
city: Grosseto
country: Italy
facility: Pfizer Investigational Site
city: Gubbio (PG)
country: Italy
facility: Pfizer Investigational Site
city: Gubbio
country: Italy
facility: Pfizer Investigational Site
city: Imperia
country: Italy
facility: Pfizer Investigational Site
city: L'Aquila
country: Italy
facility: Pfizer Investigational Site
city: Latina
country: Italy
facility: Pfizer Investigational Site
city: Lecce
country: Italy
facility: Pfizer Investigational Site
city: Livorno
country: Italy
facility: Pfizer Investigational Site
city: Lucca
country: Italy
facility: Pfizer Investigational Site
city: Macerata
country: Italy
facility: Pfizer Investigational Site
city: Mantova
country: Italy
facility: Pfizer Investigational Site
city: Martina Franca
country: Italy
facility: Pfizer Investigational Site
city: Matera
country: Italy
facility: Pfizer Investigational Site
city: Messina
country: Italy
facility: Pfizer Investigational Site
city: Mestre
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Moncalieri TO
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Orvieto Scalo
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Palermo
country: Italy
facility: Pfizer Investigational Site
city: Pavia
country: Italy
facility: Pfizer Investigational Site
city: Pescara
country: Italy
facility: Pfizer Investigational Site
city: Piombino
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Pistoia
country: Italy
facility: Pfizer Investigational Site
city: Popoli (Pe)
country: Italy
facility: Pfizer Investigational Site
city: Potenza
country: Italy
facility: Pfizer Investigational Site
city: Pozzilli
country: Italy
facility: Pfizer Investigational Site
city: Prato
country: Italy
facility: Pfizer Investigational Site
city: Ravenna
country: Italy
facility: Pfizer Investigational Site
city: Reggio Emilia
country: Italy
facility: Pfizer Investigational Site
city: Rho (MI)
country: Italy
facility: Pfizer Investigational Site
city: Rimini
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: S. Giovanni Rotondo
country: Italy
facility: Pfizer Investigational Site
city: San Bonifacio
country: Italy
facility: Pfizer Investigational Site
city: San Felice a Cancello
country: Italy
facility: Pfizer Investigational Site
city: San Giovanni Rotondo
country: Italy
facility: Pfizer Investigational Site
city: San Vito Al Tagliamento
country: Italy
facility: Pfizer Investigational Site
city: Sant' Omero ( Te)
country: Italy
facility: Pfizer Investigational Site
city: Sassari
country: Italy
facility: Pfizer Investigational Site
city: Savigliano
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Taranto
country: Italy
facility: Pfizer Investigational Site
city: Telese Terme
country: Italy
facility: Pfizer Investigational Site
city: Termoli
country: Italy
facility: Pfizer Investigational Site
city: Todi
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Torre Del Greco (NA)
country: Italy
facility: Pfizer Investigational Site
city: Trieste
country: Italy
facility: Pfizer Investigational Site
city: Udine
country: Italy
facility: Pfizer Investigational Site
city: Varese
country: Italy
facility: Pfizer Investigational Site
city: Velletri
country: Italy
facility: Pfizer Investigational Site
city: Vibo Valentia
country: Italy
facility: Pfizer Investigational Site
city: Vicenza
country: Italy
facility: Pfizer Investigational Site
city: Vigevano
country: Italy
facility: Pfizer Investigational Site
city: Viterbo
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: