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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
indobufen
aspirin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Prevention of thromboembolic events in patients with non valvular atrial fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 24, 2005
Last Updated
December 17, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00244426
Brief Title
S.I.F.A. II: Prevention Of Thromboembolic Events In Patients With Nonrheumatic Atrial Fibrillation
Acronym
SIFA
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Prevention of thromboembolic events in patients with non valvular atrial fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1372 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
indobufen
Intervention Description
Indobufen capsules 100 and 200mg
Intervention Type
Drug
Intervention Name(s)
aspirin
Intervention Description
Acetylsalicylic acid capsules 300mg
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

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

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=293-CVD-9010-004&StudyName=S.I.F.A.%20II%3A%20Prevention%20Of%20Thromboembolic%20Events%20In%20Patients%20With%20Nonrheumatic%20Atrial%20Fibrillation.
Description
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S.I.F.A. II: Prevention Of Thromboembolic Events In Patients With Nonrheumatic Atrial Fibrillation

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