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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00244426
Collaborator
(none)
1,372
Enrollment
132
Locations
2
Arms
88
Duration (Months)
10.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1372 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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 Start Date :
Dec 1, 2000
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Apr 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: indobufen
Indobufen capsules 100 and 200mg
Active Comparator: 2

Drug: aspirin
Acetylsalicylic acid capsules 300mg

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Global mortality, ischemic ictus, disabling ictus, TIA, nonfatal acute myocardial infarction, fatal and nonfatal hemorrhagic events, fatal and nonfatal embolisms. [3.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Lagosanto FE Italy 44023
2 Pfizer Investigational Site Perugia PG Italy 06100
3 Pfizer Investigational Site Perugia PG Italy 06123
4 Pfizer Investigational Site Poggibonsi SI Italy 53036
5 Pfizer Investigational Site Siena SI Italy 53100
6 Pfizer Investigational Site Busto Arsizio VA Italy 21052
7 Pfizer Investigational Site Peschiera Del Garda VR Italy 37019
8 Pfizer Investigational Site Abbadia S. Salvatore (SI) Italy 53021
9 Pfizer Investigational Site Acquaviva Delle Fonti (BA) Italy 70021
10 Pfizer Investigational Site Albano Laziale Italy 00041
11 Pfizer Investigational Site Alessandria Italy
12 Pfizer Investigational Site Ancona Italy 60122
13 Pfizer Investigational Site Ancona Italy 60131
14 Pfizer Investigational Site Angera Italy 21021
15 Pfizer Investigational Site Antella Italy 50011
16 Pfizer Investigational Site Aosta Italy 11100
17 Pfizer Investigational Site Arezzo Italy 52100
18 Pfizer Investigational Site Assisi Italy 06081
19 Pfizer Investigational Site Asti Italy 14100
20 Pfizer Investigational Site Avellino Italy 83100
21 Pfizer Investigational Site Bari Italy 70121
22 Pfizer Investigational Site Bari Italy 70123
23 Pfizer Investigational Site Bentivoglio Italy
24 Pfizer Investigational Site Bergamo Italy 24100
25 Pfizer Investigational Site Bologna Italy 40100
26 Pfizer Investigational Site Bologna Italy 40137
27 Pfizer Investigational Site Bologna Italy 40138
28 Pfizer Investigational Site Brindisi Italy 72100
29 Pfizer Investigational Site Cagliari Italy 09122
30 Pfizer Investigational Site Carbonia Italy 09013
31 Pfizer Investigational Site Casarano (LE) Italy 73042
32 Pfizer Investigational Site Casarano Italy 73022
33 Pfizer Investigational Site Caserta Italy 81100
34 Pfizer Investigational Site Cassano Delle Murge (BA) Italy 70020
35 Pfizer Investigational Site Castelfranco Veneto Italy 31033
36 Pfizer Investigational Site Castiglion Del Lago Italy 06062
37 Pfizer Investigational Site Catania Italy 95122
38 Pfizer Investigational Site Catania Italy 95123
39 Pfizer Investigational Site Catania Italy 95124
40 Pfizer Investigational Site Catania Italy 95126
41 Pfizer Investigational Site Catanzaro Italy 88100
42 Pfizer Investigational Site Cesena Italy 47023
43 Pfizer Investigational Site Chieti Italy 66013
44 Pfizer Investigational Site Cirie (TO) Italy 10073
45 Pfizer Investigational Site Citta della Pieve Italy 06062
46 Pfizer Investigational Site Citta' Di Castello (Pg) Italy 06012
47 Pfizer Investigational Site Cittadella Italy 35013
48 Pfizer Investigational Site Copertino Italy 73043
49 Pfizer Investigational Site Cosenza Italy 87100
50 Pfizer Investigational Site Cremona Italy 26100
51 Pfizer Investigational Site Cuneo Italy 12100
52 Pfizer Investigational Site Desio Italy 20033
53 Pfizer Investigational Site Eboli (SA) Italy
54 Pfizer Investigational Site Faenza Italy
55 Pfizer Investigational Site Fidenza Italy 43036
56 Pfizer Investigational Site Firenze Italy 50134
57 Pfizer Investigational Site Firenze Italy 50139
58 Pfizer Investigational Site Firenze Italy
59 Pfizer Investigational Site Foggia Italy 71100
60 Pfizer Investigational Site Foligno Italy 06034
61 Pfizer Investigational Site Forlimpopoli (Fo) Italy 47034
62 Pfizer Investigational Site Forli Italy 47100
63 Pfizer Investigational Site Frosinone Italy 03100
64 Pfizer Investigational Site Genova Italy 16131
65 Pfizer Investigational Site Genova Italy 16164
66 Pfizer Investigational Site Giulianova Italy 64021
67 Pfizer Investigational Site Gorizia Italy 24170
68 Pfizer Investigational Site Gracciano (Si) Italy 53040
69 Pfizer Investigational Site Grosseto Italy 58100
70 Pfizer Investigational Site Gubbio (PG) Italy 06024
71 Pfizer Investigational Site Gubbio Italy
72 Pfizer Investigational Site Imperia Italy 18100
73 Pfizer Investigational Site L'Aquila Italy 67120
74 Pfizer Investigational Site Latina Italy
75 Pfizer Investigational Site Lecce Italy 73100
76 Pfizer Investigational Site Livorno Italy 57100
77 Pfizer Investigational Site Lucca Italy 55100
78 Pfizer Investigational Site Macerata Italy
79 Pfizer Investigational Site Mantova Italy
80 Pfizer Investigational Site Martina Franca Italy 74015
81 Pfizer Investigational Site Matera Italy 75100
82 Pfizer Investigational Site Messina Italy 98122
83 Pfizer Investigational Site Mestre Italy
84 Pfizer Investigational Site Milano Italy 20153
85 Pfizer Investigational Site Milano Italy 20159
86 Pfizer Investigational Site Moncalieri TO Italy
87 Pfizer Investigational Site Napoli Italy 80142
88 Pfizer Investigational Site Orvieto Scalo Italy 05018
89 Pfizer Investigational Site Padova Italy 35128
90 Pfizer Investigational Site Palermo Italy 90144
91 Pfizer Investigational Site Pavia Italy 27100
92 Pfizer Investigational Site Pescara Italy 65100
93 Pfizer Investigational Site Piombino Italy 57100
94 Pfizer Investigational Site Pisa Italy 56124
95 Pfizer Investigational Site Pistoia Italy
96 Pfizer Investigational Site Popoli (Pe) Italy 65026
97 Pfizer Investigational Site Potenza Italy 85100
98 Pfizer Investigational Site Pozzilli Italy 86077
99 Pfizer Investigational Site Prato Italy 59100
100 Pfizer Investigational Site Ravenna Italy 48100
101 Pfizer Investigational Site Reggio Emilia Italy 42100
102 Pfizer Investigational Site Rho (MI) Italy 20017
103 Pfizer Investigational Site Rimini Italy 47900
104 Pfizer Investigational Site Roma Italy 00161
105 Pfizer Investigational Site Roma Italy 00184
106 Pfizer Investigational Site Roma Italy 00185
107 Pfizer Investigational Site Roma Italy 00189
108 Pfizer Investigational Site S. Giovanni Rotondo Italy 71013
109 Pfizer Investigational Site San Bonifacio Italy
110 Pfizer Investigational Site San Felice a Cancello Italy
111 Pfizer Investigational Site San Giovanni Rotondo Italy 71013
112 Pfizer Investigational Site San Vito Al Tagliamento Italy 33078
113 Pfizer Investigational Site Sant' Omero ( Te) Italy 64027
114 Pfizer Investigational Site Sassari Italy 07100
115 Pfizer Investigational Site Savigliano Italy 12038
116 Pfizer Investigational Site Siena Italy 53100
117 Pfizer Investigational Site Taranto Italy 74100
118 Pfizer Investigational Site Telese Terme Italy 82037
119 Pfizer Investigational Site Termoli Italy
120 Pfizer Investigational Site Todi Italy 06059
121 Pfizer Investigational Site Torino Italy 10125
122 Pfizer Investigational Site Torino Italy 10126
123 Pfizer Investigational Site Torino Italy 10128
124 Pfizer Investigational Site Torre Del Greco (NA) Italy 80059
125 Pfizer Investigational Site Trieste Italy
126 Pfizer Investigational Site Udine Italy 33100
127 Pfizer Investigational Site Varese Italy 21100
128 Pfizer Investigational Site Velletri Italy 00049
129 Pfizer Investigational Site Vibo Valentia Italy 89900
130 Pfizer Investigational Site Vicenza Italy 36100
131 Pfizer Investigational Site Vigevano Italy 27029
132 Pfizer Investigational Site Viterbo Italy 01100

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00244426
Other Study ID Numbers:
  • 293-CVD-9010-004
  • A7651004
First Posted:
Oct 26, 2005
Last Update Posted:
Dec 19, 2018
Last Verified:
Dec 1, 2018
Keywords provided by , ,
Prevention of thromboembolic events in patients with non valvular atrial fibrillation
Additional relevant MeSH terms:
Atrial Fibrillation
Thromboembolism
Aspirin
Indobufen

Study Results

No Results Posted as of Dec 19, 2018