S.I.F.A. II: Prevention Of Thromboembolic Events In Patients With Nonrheumatic Atrial Fibrillation

NCT00244426 | Completed Phase 3

• 2 other identifiers: 293-CVD-9010-004A7651004
• Study Type: interventional
• Target: 1,372
• Locations: 1 country
• Sites: 132

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.

Conditions

Atrial Fibrillation

Keywords

Prevention of thromboembolic events in patients with non valvular atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Global mortality, ischemic ictus, disabling ictus, TIA, nonfatal acute myocardial infarction, fatal and nonfatal hemorrhagic events, fatal and nonfatal embolisms.

  3.5 years

Study Arms (2)

1

EXPERIMENTAL

Drug: indobufen

2

ACTIVE COMPARATOR

Drug: aspirin

Interventions

indobufen DRUG

Indobufen capsules 100 and 200mg

1

aspirin DRUG

Acetylsalicylic acid capsules 300mg

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (132)

Pfizer Investigational Site

Lagosanto, FE, 44023, Italy

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Perugia, PG, 06100, Italy

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Perugia, PG, 06123, Italy

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Poggibonsi, SI, 53036, Italy

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Siena, SI, 53100, Italy

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Busto Arsizio, VA, 21052, Italy

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Peschiera del Garda, VR, 37019, Italy

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Abbadia S. Salvatore (SI), 53021, Italy

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Acquaviva Delle Fonti (BA), 70021, Italy

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Albano Laziale, 00041, Italy

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Alessandria, Italy

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Ancona, 60122, Italy

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Ancona, 60131, Italy

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Angera, 21021, Italy

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Antella, 50011, Italy

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Aosta, 11100, Italy

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Arezzo, 52100, Italy

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Assisi, 06081, Italy

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Asti, 14100, Italy

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Avellino, 83100, Italy

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Bari, 70121, Italy

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Bari, 70123, Italy

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Bentivoglio, Italy

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Bergamo, 24100, Italy

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Bologna, 40100, Italy

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Bologna, 40137, Italy

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Bologna, 40138, Italy

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Brindisi, 72100, Italy

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Cagliari, 09122, Italy

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Carbonia, 09013, Italy

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Casarano, 73022, Italy

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Casarano (LE), 73042, Italy

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Caserta, 81100, Italy

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Cassano Delle Murge (BA), 70020, Italy

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Castelfranco Veneto, 31033, Italy

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Castiglion Del Lago, 06062, Italy

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Catania, 95122, Italy

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Catania, 95123, Italy

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Catania, 95124, Italy

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Catania, 95126, Italy

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Catanzaro, 88100, Italy

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Cesena, 47023, Italy

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Chieti, 66013, Italy

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Cirie (TO), 10073, Italy

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Citta' Di Castello (Pg), 06012, Italy

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Cittadella, 35013, Italy

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Città della Pieve, 06062, Italy

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Copertino, 73043, Italy

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Cosenza, 87100, Italy

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Cremona, 26100, Italy

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Cuneo, 12100, Italy

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Desio, 20033, Italy

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Eboli (SA), Italy

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Faenza, Italy

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Fidenza, 43036, Italy

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Florence, 50134, Italy

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Florence, 50139, Italy

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Florence, Italy

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Foggia, 71100, Italy

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Foligno, 06034, Italy

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Forlimpopoli (Fo), 47034, Italy

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Forlì, 47100, Italy

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Frosinone, 03100, Italy

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Genova, 16131, Italy

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Genova, 16164, Italy

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Giulianova, 64021, Italy

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Gorizia, 24170, Italy

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Gracciano (Si), 53040, Italy

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Grosseto, 58100, Italy

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Gubbio, Italy

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Gubbio (PG), 06024, Italy

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Imperia, 18100, Italy

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Latina, Italy

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Lecce, 73100, Italy

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Livorno, 57100, Italy

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Lucca, 55100, Italy

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L’Aquila, 67120, Italy

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Macerata, Italy

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Mantova, Italy

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Martina Franca, 74015, Italy

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Matera, 75100, Italy

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Messina, 98122, Italy

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Mestre, Italy

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Milan, 20153, Italy

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Milan, 20159, Italy

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Moncalieri to, Italy

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Napoli, 80142, Italy

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Orvieto Scalo, 05018, Italy

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Padua, 35128, Italy

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Palermo, 90144, Italy

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Pavia, 27100, Italy

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Pescara, 65100, Italy

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Piombino, 57100, Italy

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Pisa, 56124, Italy

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Pistoia, Italy

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Popoli (Pe), 65026, Italy

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Potenza, 85100, Italy

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Pozzilli, 86077, Italy

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Prato, 59100, Italy

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Ravenna, 48100, Italy

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Reggio Emilia, 42100, Italy

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Rho (MI), 20017, Italy

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Rimini, 47900, Italy

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Roma, 00161, Italy

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Roma, 00184, Italy

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Roma, 00185, Italy

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Roma, 00189, Italy

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S. Giovanni Rotondo, 71013, Italy

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San Bonifacio, Italy

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San Felice A Cancello, Italy

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San Giovanni Rotondo, 71013, Italy

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San Vito al Tagliamento, 33078, Italy

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Sant' Omero ( Te), 64027, Italy

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Sassari, 07100, Italy

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Savigliano, 12038, Italy

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Siena, 53100, Italy

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Taranto, 74100, Italy

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Telese Terme, 82037, Italy

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Termoli, Italy

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Todi, 06059, Italy

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Torino, 10125, Italy

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Torino, 10126, Italy

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Torino, 10128, Italy

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Torre Del Greco (NA), 80059, Italy

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Trieste, Italy

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Udine, 33100, Italy

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Varese, 21100, Italy

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Velletri, 00049, Italy

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Vibo Valentia, 89900, Italy

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Vicenza, 36100, Italy

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Vigevano, 27029, Italy

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Pfizer Investigational Site

Viterbo, 01100, Italy

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

indobufen; Aspirin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 24, 2005
• First Posted: October 26, 2005
• Study Start: December 1, 2000
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

IT (132)