Atrial Fibrillation Clinical Trial
— SIFAOfficial title:
II Italian Study on Atrial Fibrillation (S.I.F.A. II): Prevention of Thromboembolic Events in Patients With Non Valvular Atrial Fibrillation.
| Verified date | December 2018 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1372 |
| Est. completion date | April 2008 |
| Est. primary completion date | April 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Pfizer Investigational Site | Abbadia S. Salvatore (SI) | |
| Italy | Pfizer Investigational Site | Acquaviva Delle Fonti (BA) | |
| Italy | Pfizer Investigational Site | Albano Laziale | |
| Italy | Pfizer Investigational Site | Alessandria | |
| Italy | Pfizer Investigational Site | Ancona | |
| Italy | Pfizer Investigational Site | Ancona | |
| Italy | Pfizer Investigational Site | Angera | |
| Italy | Pfizer Investigational Site | Antella | |
| Italy | Pfizer Investigational Site | Aosta | |
| Italy | Pfizer Investigational Site | Arezzo | |
| Italy | Pfizer Investigational Site | Assisi | |
| Italy | Pfizer Investigational Site | Asti | |
| Italy | Pfizer Investigational Site | Avellino | |
| Italy | Pfizer Investigational Site | Bari | |
| Italy | Pfizer Investigational Site | Bari | |
| Italy | Pfizer Investigational Site | Bentivoglio | |
| Italy | Pfizer Investigational Site | Bergamo | |
| Italy | Pfizer Investigational Site | Bologna | |
| Italy | Pfizer Investigational Site | Bologna | |
| Italy | Pfizer Investigational Site | Bologna | |
| Italy | Pfizer Investigational Site | Brindisi | |
| Italy | Pfizer Investigational Site | Busto Arsizio | VA |
| Italy | Pfizer Investigational Site | Cagliari | |
| Italy | Pfizer Investigational Site | Carbonia | |
| Italy | Pfizer Investigational Site | Casarano | |
| Italy | Pfizer Investigational Site | Casarano (LE) | |
| Italy | Pfizer Investigational Site | Caserta | |
| Italy | Pfizer Investigational Site | Cassano Delle Murge (BA) | |
| Italy | Pfizer Investigational Site | Castelfranco Veneto | |
| Italy | Pfizer Investigational Site | Castiglion Del Lago | |
| Italy | Pfizer Investigational Site | Catania | |
| Italy | Pfizer Investigational Site | Catania | |
| Italy | Pfizer Investigational Site | Catania | |
| Italy | Pfizer Investigational Site | Catania | |
| Italy | Pfizer Investigational Site | Catanzaro | |
| Italy | Pfizer Investigational Site | Cesena | |
| Italy | Pfizer Investigational Site | Chieti | |
| Italy | Pfizer Investigational Site | Cirie (TO) | |
| Italy | Pfizer Investigational Site | Citta della Pieve | |
| Italy | Pfizer Investigational Site | Citta' Di Castello (Pg) | |
| Italy | Pfizer Investigational Site | Cittadella | |
| Italy | Pfizer Investigational Site | Copertino | |
| Italy | Pfizer Investigational Site | Cosenza | |
| Italy | Pfizer Investigational Site | Cremona | |
| Italy | Pfizer Investigational Site | Cuneo | |
| Italy | Pfizer Investigational Site | Desio | |
| Italy | Pfizer Investigational Site | Eboli (SA) | |
| Italy | Pfizer Investigational Site | Faenza | |
| Italy | Pfizer Investigational Site | Fidenza | |
| Italy | Pfizer Investigational Site | Firenze | |
| Italy | Pfizer Investigational Site | Firenze | |
| Italy | Pfizer Investigational Site | Firenze | |
| Italy | Pfizer Investigational Site | Foggia | |
| Italy | Pfizer Investigational Site | Foligno | |
| Italy | Pfizer Investigational Site | Forli | |
| Italy | Pfizer Investigational Site | Forlimpopoli (Fo) | |
| Italy | Pfizer Investigational Site | Frosinone | |
| Italy | Pfizer Investigational Site | Genova | |
| Italy | Pfizer Investigational Site | Genova | |
| Italy | Pfizer Investigational Site | Giulianova | |
| Italy | Pfizer Investigational Site | Gorizia | |
| Italy | Pfizer Investigational Site | Gracciano (Si) | |
| Italy | Pfizer Investigational Site | Grosseto | |
| Italy | Pfizer Investigational Site | Gubbio | |
| Italy | Pfizer Investigational Site | Gubbio (PG) | |
| Italy | Pfizer Investigational Site | Imperia | |
| Italy | Pfizer Investigational Site | L'Aquila | |
| Italy | Pfizer Investigational Site | Lagosanto | FE |
| Italy | Pfizer Investigational Site | Latina | |
| Italy | Pfizer Investigational Site | Lecce | |
| Italy | Pfizer Investigational Site | Livorno | |
| Italy | Pfizer Investigational Site | Lucca | |
| Italy | Pfizer Investigational Site | Macerata | |
| Italy | Pfizer Investigational Site | Mantova | |
| Italy | Pfizer Investigational Site | Martina Franca | |
| Italy | Pfizer Investigational Site | Matera | |
| Italy | Pfizer Investigational Site | Messina | |
| Italy | Pfizer Investigational Site | Mestre | |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Moncalieri TO | |
| Italy | Pfizer Investigational Site | Napoli | |
| Italy | Pfizer Investigational Site | Orvieto Scalo | |
| Italy | Pfizer Investigational Site | Padova | |
| Italy | Pfizer Investigational Site | Palermo | |
| Italy | Pfizer Investigational Site | Pavia | |
| Italy | Pfizer Investigational Site | Perugia | PG |
| Italy | Pfizer Investigational Site | Perugia | PG |
| Italy | Pfizer Investigational Site | Pescara | |
| Italy | Pfizer Investigational Site | Peschiera Del Garda | VR |
| Italy | Pfizer Investigational Site | Piombino | |
| Italy | Pfizer Investigational Site | Pisa | |
| Italy | Pfizer Investigational Site | Pistoia | |
| Italy | Pfizer Investigational Site | Poggibonsi | SI |
| Italy | Pfizer Investigational Site | Popoli (Pe) | |
| Italy | Pfizer Investigational Site | Potenza | |
| Italy | Pfizer Investigational Site | Pozzilli | |
| Italy | Pfizer Investigational Site | Prato | |
| Italy | Pfizer Investigational Site | Ravenna | |
| Italy | Pfizer Investigational Site | Reggio Emilia | |
| Italy | Pfizer Investigational Site | Rho (MI) | |
| Italy | Pfizer Investigational Site | Rimini | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | S. Giovanni Rotondo | |
| Italy | Pfizer Investigational Site | San Bonifacio | |
| Italy | Pfizer Investigational Site | San Felice a Cancello | |
| Italy | Pfizer Investigational Site | San Giovanni Rotondo | |
| Italy | Pfizer Investigational Site | San Vito Al Tagliamento | |
| Italy | Pfizer Investigational Site | Sant' Omero ( Te) | |
| Italy | Pfizer Investigational Site | Sassari | |
| Italy | Pfizer Investigational Site | Savigliano | |
| Italy | Pfizer Investigational Site | Siena | |
| Italy | Pfizer Investigational Site | Siena | SI |
| Italy | Pfizer Investigational Site | Taranto | |
| Italy | Pfizer Investigational Site | Telese Terme | |
| Italy | Pfizer Investigational Site | Termoli | |
| Italy | Pfizer Investigational Site | Todi | |
| Italy | Pfizer Investigational Site | Torino | |
| Italy | Pfizer Investigational Site | Torino | |
| Italy | Pfizer Investigational Site | Torino | |
| Italy | Pfizer Investigational Site | Torre Del Greco (NA) | |
| Italy | Pfizer Investigational Site | Trieste | |
| Italy | Pfizer Investigational Site | Udine | |
| Italy | Pfizer Investigational Site | Varese | |
| Italy | Pfizer Investigational Site | Velletri | |
| Italy | Pfizer Investigational Site | Vibo Valentia | |
| Italy | Pfizer Investigational Site | Vicenza | |
| Italy | Pfizer Investigational Site | Vigevano | |
| Italy | Pfizer Investigational Site | Viterbo |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 3.5 years | ||
| Secondary | Global mortality, ischemic ictus, disabling ictus, TIA, nonfatal acute myocardial infarction, fatal and nonfatal hemorrhagic events, fatal and nonfatal embolisms. | 3.5 years |
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