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

December 17, 2018 updated by: Pfizer

II Italian Study on Atrial Fibrillation (S.I.F.A. II): Prevention of Thromboembolic Events in Patients With Non Valvular Atrial Fibrillation.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1372

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Abbadia S. Salvatore (SI), Italy, 53021
        • Pfizer Investigational Site
      • Acquaviva Delle Fonti (BA), Italy, 70021
        • Pfizer Investigational Site
      • Albano Laziale, Italy, 00041
        • Pfizer Investigational Site
      • Alessandria, Italy
        • Pfizer Investigational Site
      • Ancona, Italy, 60122
        • Pfizer Investigational Site
      • Ancona, Italy, 60131
        • Pfizer Investigational Site
      • Angera, Italy, 21021
        • Pfizer Investigational Site
      • Antella, Italy, 50011
        • Pfizer Investigational Site
      • Aosta, Italy, 11100
        • Pfizer Investigational Site
      • Arezzo, Italy, 52100
        • Pfizer Investigational Site
      • Assisi, Italy, 06081
        • Pfizer Investigational Site
      • Asti, Italy, 14100
        • Pfizer Investigational Site
      • Avellino, Italy, 83100
        • Pfizer Investigational Site
      • Bari, Italy, 70121
        • Pfizer Investigational Site
      • Bari, Italy, 70123
        • Pfizer Investigational Site
      • Bentivoglio, Italy
        • Pfizer Investigational Site
      • Bergamo, Italy, 24100
        • Pfizer Investigational Site
      • Bologna, Italy, 40138
        • Pfizer Investigational Site
      • Bologna, Italy, 40100
        • Pfizer Investigational Site
      • Bologna, Italy, 40137
        • Pfizer Investigational Site
      • Brindisi, Italy, 72100
        • Pfizer Investigational Site
      • Cagliari, Italy, 09122
        • Pfizer Investigational Site
      • Carbonia, Italy, 09013
        • Pfizer Investigational Site
      • Casarano, Italy, 73022
        • Pfizer Investigational Site
      • Casarano (LE), Italy, 73042
        • Pfizer Investigational Site
      • Caserta, Italy, 81100
        • Pfizer Investigational Site
      • Cassano Delle Murge (BA), Italy, 70020
        • Pfizer Investigational Site
      • Castelfranco Veneto, Italy, 31033
        • Pfizer Investigational Site
      • Castiglion Del Lago, Italy, 06062
        • Pfizer Investigational Site
      • Catania, Italy, 95126
        • Pfizer Investigational Site
      • Catania, Italy, 95122
        • Pfizer Investigational Site
      • Catania, Italy, 95123
        • Pfizer Investigational Site
      • Catania, Italy, 95124
        • Pfizer Investigational Site
      • Catanzaro, Italy, 88100
        • Pfizer Investigational Site
      • Cesena, Italy, 47023
        • Pfizer Investigational Site
      • Chieti, Italy, 66013
        • Pfizer Investigational Site
      • Cirie (TO), Italy, 10073
        • Pfizer Investigational Site
      • Citta della Pieve, Italy, 06062
        • Pfizer Investigational Site
      • Citta' Di Castello (Pg), Italy, 06012
        • Pfizer Investigational Site
      • Cittadella, Italy, 35013
        • Pfizer Investigational Site
      • Copertino, Italy, 73043
        • Pfizer Investigational Site
      • Cosenza, Italy, 87100
        • Pfizer Investigational Site
      • Cremona, Italy, 26100
        • Pfizer Investigational Site
      • Cuneo, Italy, 12100
        • Pfizer Investigational Site
      • Desio, Italy, 20033
        • Pfizer Investigational Site
      • Eboli (SA), Italy
        • Pfizer Investigational Site
      • Faenza, Italy
        • Pfizer Investigational Site
      • Fidenza, Italy, 43036
        • Pfizer Investigational Site
      • Firenze, Italy, 50134
        • Pfizer Investigational Site
      • Firenze, Italy, 50139
        • Pfizer Investigational Site
      • Firenze, Italy
        • Pfizer Investigational Site
      • Foggia, Italy, 71100
        • Pfizer Investigational Site
      • Foligno, Italy, 06034
        • Pfizer Investigational Site
      • Forli, Italy, 47100
        • Pfizer Investigational Site
      • Forlimpopoli (Fo), Italy, 47034
        • Pfizer Investigational Site
      • Frosinone, Italy, 03100
        • Pfizer Investigational Site
      • Genova, Italy, 16131
        • Pfizer Investigational Site
      • Genova, Italy, 16164
        • Pfizer Investigational Site
      • Giulianova, Italy, 64021
        • Pfizer Investigational Site
      • Gorizia, Italy, 24170
        • Pfizer Investigational Site
      • Gracciano (Si), Italy, 53040
        • Pfizer Investigational Site
      • Grosseto, Italy, 58100
        • Pfizer Investigational Site
      • Gubbio, Italy
        • Pfizer Investigational Site
      • Gubbio (PG), Italy, 06024
        • Pfizer Investigational Site
      • Imperia, Italy, 18100
        • Pfizer Investigational Site
      • L'Aquila, Italy, 67120
        • Pfizer Investigational Site
      • Latina, Italy
        • Pfizer Investigational Site
      • Lecce, Italy, 73100
        • Pfizer Investigational Site
      • Livorno, Italy, 57100
        • Pfizer Investigational Site
      • Lucca, Italy, 55100
        • Pfizer Investigational Site
      • Macerata, Italy
        • Pfizer Investigational Site
      • Mantova, Italy
        • Pfizer Investigational Site
      • Martina Franca, Italy, 74015
        • Pfizer Investigational Site
      • Matera, Italy, 75100
        • Pfizer Investigational Site
      • Messina, Italy, 98122
        • Pfizer Investigational Site
      • Mestre, Italy
        • Pfizer Investigational Site
      • Milano, Italy, 20153
        • Pfizer Investigational Site
      • Milano, Italy, 20159
        • Pfizer Investigational Site
      • Moncalieri TO, Italy
        • Pfizer Investigational Site
      • Napoli, Italy, 80142
        • Pfizer Investigational Site
      • Orvieto Scalo, Italy, 05018
        • Pfizer Investigational Site
      • Padova, Italy, 35128
        • Pfizer Investigational Site
      • Palermo, Italy, 90144
        • Pfizer Investigational Site
      • Pavia, Italy, 27100
        • Pfizer Investigational Site
      • Pescara, Italy, 65100
        • Pfizer Investigational Site
      • Piombino, Italy, 57100
        • Pfizer Investigational Site
      • Pisa, Italy, 56124
        • Pfizer Investigational Site
      • Pistoia, Italy
        • Pfizer Investigational Site
      • Popoli (Pe), Italy, 65026
        • Pfizer Investigational Site
      • Potenza, Italy, 85100
        • Pfizer Investigational Site
      • Pozzilli, Italy, 86077
        • Pfizer Investigational Site
      • Prato, Italy, 59100
        • Pfizer Investigational Site
      • Ravenna, Italy, 48100
        • Pfizer Investigational Site
      • Reggio Emilia, Italy, 42100
        • Pfizer Investigational Site
      • Rho (MI), Italy, 20017
        • Pfizer Investigational Site
      • Rimini, Italy, 47900
        • Pfizer Investigational Site
      • Roma, Italy, 00189
        • Pfizer Investigational Site
      • Roma, Italy, 00161
        • Pfizer Investigational Site
      • Roma, Italy, 00184
        • Pfizer Investigational Site
      • Roma, Italy, 00185
        • Pfizer Investigational Site
      • S. Giovanni Rotondo, Italy, 71013
        • Pfizer Investigational Site
      • San Bonifacio, Italy
        • Pfizer Investigational Site
      • San Felice a Cancello, Italy
        • Pfizer Investigational Site
      • San Giovanni Rotondo, Italy, 71013
        • Pfizer Investigational Site
      • San Vito Al Tagliamento, Italy, 33078
        • Pfizer Investigational Site
      • Sant' Omero ( Te), Italy, 64027
        • Pfizer Investigational Site
      • Sassari, Italy, 07100
        • Pfizer Investigational Site
      • Savigliano, Italy, 12038
        • Pfizer Investigational Site
      • Siena, Italy, 53100
        • Pfizer Investigational Site
      • Taranto, Italy, 74100
        • Pfizer Investigational Site
      • Telese Terme, Italy, 82037
        • Pfizer Investigational Site
      • Termoli, Italy
        • Pfizer Investigational Site
      • Todi, Italy, 06059
        • Pfizer Investigational Site
      • Torino, Italy, 10126
        • Pfizer Investigational Site
      • Torino, Italy, 10125
        • Pfizer Investigational Site
      • Torino, Italy, 10128
        • Pfizer Investigational Site
      • Torre Del Greco (NA), Italy, 80059
        • Pfizer Investigational Site
      • Trieste, Italy
        • Pfizer Investigational Site
      • Udine, Italy, 33100
        • Pfizer Investigational Site
      • Varese, Italy, 21100
        • Pfizer Investigational Site
      • Velletri, Italy, 00049
        • Pfizer Investigational Site
      • Vibo Valentia, Italy, 89900
        • Pfizer Investigational Site
      • Vicenza, Italy, 36100
        • Pfizer Investigational Site
      • Vigevano, Italy, 27029
        • Pfizer Investigational Site
      • Viterbo, Italy, 01100
        • Pfizer Investigational Site
    • FE
      • Lagosanto, FE, Italy, 44023
        • Pfizer Investigational Site
    • PG
      • Perugia, PG, Italy, 06100
        • Pfizer Investigational Site
      • Perugia, PG, Italy, 06123
        • Pfizer Investigational Site
    • SI
      • Poggibonsi, SI, Italy, 53036
        • Pfizer Investigational Site
      • Siena, SI, Italy, 53100
        • Pfizer Investigational Site
    • VA
      • Busto Arsizio, VA, Italy, 21052
        • Pfizer Investigational Site
    • VR
      • Peschiera Del Garda, VR, Italy, 37019
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: indobufen
Indobufen capsules 100 and 200mg
Active Comparator: 2
Drug: aspirin
Acetylsalicylic acid capsules 300mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 3.5 years
3.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Global mortality, ischemic ictus, disabling ictus, TIA, nonfatal acute myocardial infarction, fatal and nonfatal hemorrhagic events, fatal and nonfatal embolisms.
Time Frame: 3.5 years
3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

October 24, 2005

First Submitted That Met QC Criteria

October 24, 2005

First Posted (Estimate)

October 26, 2005

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 293-CVD-9010-004
  • A7651004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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