Atrial FibrillationPhase 3SIFANCT00244426
S.I.F.A. II: Prevention Of Thromboembolic Events In Patients With Nonrheumatic Atrial Fibrillation
A Phase 3 study testing indobufen and aspirin in people with Atrial Fibrillation, run by Pfizer at 132 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- indobufen and aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,372 participants
- Where
- 132 sitesItaly
- Study dates
- Dec 2000to Apr 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic or paroxysmal non rheumatic atrial fibrillation with cardioembolic risk factors: hypertension, ischemic cardiopathy, Congestive Heart Failure, diabetes mellitus
Who cannot join
- Clinically relevant organ disease
- creatinine clearance < 30 ml/min
- gastric or duodenal ulcer
- severe anaemia or poliglobulia
Trial locations and contacts
132 sites in 1 country.
132 sites in 1 country
Italy132 sites
Pfizer Investigational Site
Abbadia S. Salvatore (SI), 53021
Pfizer Investigational Site
Acquaviva Delle Fonti (BA), 70021
Pfizer Investigational Site
Albano Laziale, 00041
Pfizer Investigational Site
Alessandria
Pfizer Investigational Site
Ancona, 60122
Pfizer Investigational Site
Ancona, 60131
Pfizer Investigational Site
Angera, 21021
Pfizer Investigational Site
Antella, 50011
Pfizer Investigational Site
Aosta, 11100
Pfizer Investigational Site
Arezzo, 52100
Pfizer Investigational Site
Assisi, 06081
Pfizer Investigational Site
Asti, 14100
Pfizer Investigational Site
Avellino, 83100
Pfizer Investigational Site
Bari, 70121
Pfizer Investigational Site
Bari, 70123
Pfizer Investigational Site
Bentivoglio
Pfizer Investigational Site
Bergamo, 24100
Pfizer Investigational Site
Bologna, 40100
Pfizer Investigational Site
Bologna, 40137
Pfizer Investigational Site
Bologna, 40138
Pfizer Investigational Site
Brindisi, 72100
Pfizer Investigational Site
Busto Arsizio, VA, 21052
Pfizer Investigational Site
Cagliari, 09122
Pfizer Investigational Site
Carbonia, 09013
Pfizer Investigational Site
Casarano, 73022
Pfizer Investigational Site
Casarano (LE), 73042
Pfizer Investigational Site
Caserta, 81100
Pfizer Investigational Site
Cassano Delle Murge (BA), 70020
Pfizer Investigational Site
Castelfranco Veneto, 31033
Pfizer Investigational Site
Castiglion Del Lago, 06062
Pfizer Investigational Site
Catania, 95122
Pfizer Investigational Site
Catania, 95123
Pfizer Investigational Site
Catania, 95124
Pfizer Investigational Site
Catania, 95126
Pfizer Investigational Site
Catanzaro, 88100
Pfizer Investigational Site
Cesena, 47023
Pfizer Investigational Site
Chieti, 66013
Pfizer Investigational Site
Cirie (TO), 10073
Pfizer Investigational Site
Città della Pieve, 06062
Pfizer Investigational Site
Citta' Di Castello (Pg), 06012
Pfizer Investigational Site
Cittadella, 35013
Pfizer Investigational Site
Copertino, 73043
Pfizer Investigational Site
Cosenza, 87100
Pfizer Investigational Site
Cremona, 26100
Pfizer Investigational Site
Cuneo, 12100
Pfizer Investigational Site
Desio, 20033
Pfizer Investigational Site
Eboli (SA)
Pfizer Investigational Site
Faenza
Pfizer Investigational Site
Fidenza, 43036
Pfizer Investigational Site
Florence, 50134
Pfizer Investigational Site
Florence, 50139
Pfizer Investigational Site
Florence
Pfizer Investigational Site
Foggia, 71100
Pfizer Investigational Site
Foligno, 06034
Pfizer Investigational Site
Forlì, 47100
Pfizer Investigational Site
Forlimpopoli (Fo), 47034
Pfizer Investigational Site
Frosinone, 03100
Pfizer Investigational Site
Genova, 16131
Pfizer Investigational Site
Genova, 16164
Pfizer Investigational Site
Giulianova, 64021
Pfizer Investigational Site
Gorizia, 24170
Pfizer Investigational Site
Gracciano (Si), 53040
Pfizer Investigational Site
Grosseto, 58100
Pfizer Investigational Site
Gubbio
Pfizer Investigational Site
Gubbio (PG), 06024
Pfizer Investigational Site
Imperia, 18100
Pfizer Investigational Site
L’Aquila, 67120
Pfizer Investigational Site
Lagosanto, FE, 44023
Pfizer Investigational Site
Latina
Pfizer Investigational Site
Lecce, 73100
Pfizer Investigational Site
Livorno, 57100
Pfizer Investigational Site
Lucca, 55100
Pfizer Investigational Site
Mantua
Pfizer Investigational Site
Martina Franca, 74015
Pfizer Investigational Site
Matera, 75100
Pfizer Investigational Site
Messina, 98122
Pfizer Investigational Site
Mestre
Pfizer Investigational Site
Milan, 20153
Pfizer Investigational Site
Milan, 20159
Pfizer Investigational Site
Moncalieri to
Pfizer Investigational Site
Naples, 80142
Pfizer Investigational Site
Orvieto Scalo, 05018
Pfizer Investigational Site
Padova, 35128
Pfizer Investigational Site
Palermo, 90144
Pfizer Investigational Site
Pavia, 27100
Pfizer Investigational Site
Perugia, PG, 06100
Pfizer Investigational Site
Perugia, PG, 06123
Pfizer Investigational Site
Pescara, 65100
Pfizer Investigational Site
Peschiera del Garda, VR, 37019
Pfizer Investigational Site
Piombino, 57100
Pfizer Investigational Site
Pisa, 56124
Pfizer Investigational Site
Pistoia
Pfizer Investigational Site
Poggibonsi, SI, 53036
Pfizer Investigational Site
Popoli (Pe), 65026
Pfizer Investigational Site
Potenza, 85100
Pfizer Investigational Site
Pozzilli, 86077
Pfizer Investigational Site
Prato, 59100
Pfizer Investigational Site
Province of Macerata
Pfizer Investigational Site
Ravenna, 48100
Pfizer Investigational Site
Reggio Emilia, 42100
Pfizer Investigational Site
Rho (MI), 20017
Pfizer Investigational Site
Rimini, 47900
Pfizer Investigational Site
Roma, 00161
Pfizer Investigational Site
Roma, 00184
Pfizer Investigational Site
Roma, 00185
Pfizer Investigational Site
Roma, 00189
Pfizer Investigational Site
S. Giovanni Rotondo, 71013
Pfizer Investigational Site
San Bonifacio
Pfizer Investigational Site
San Felice A Cancello
Pfizer Investigational Site
San Giovanni Rotondo, 71013
Pfizer Investigational Site
San Vito al Tagliamento, 33078
Pfizer Investigational Site
Sant' Omero ( Te), 64027
Pfizer Investigational Site
Sassari, 07100
Pfizer Investigational Site
Savigliano, 12038
Pfizer Investigational Site
Siena, SI, 53100
Pfizer Investigational Site
Siena, 53100
Pfizer Investigational Site
Taranto, 74100
Pfizer Investigational Site
Telese Terme, 82037
Pfizer Investigational Site
Termoli
Pfizer Investigational Site
Todi, 06059
Pfizer Investigational Site
Torino, 10125
Pfizer Investigational Site
Torino, 10126
Pfizer Investigational Site
Torino, 10128
Pfizer Investigational Site
Torre Del Greco (NA), 80059
Pfizer Investigational Site
Trieste
Pfizer Investigational Site
Udine, 33100
Pfizer Investigational Site
Varese, 21100
Pfizer Investigational Site
Velletri, 00049
Pfizer Investigational Site
Vibo Valentia, 89900
Pfizer Investigational Site
Vicenza, 36100
Pfizer Investigational Site
Vigevano, 27029
Pfizer Investigational Site
Viterbo, 01100
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation
- Being tested
- indobufen, aspirin
- Keywords
- Prevention of thromboembolic events in patients with non valvular atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indobufenDrug
Indobufen capsules 100 and 200mg
aspirinDrug
Acetylsalicylic acid capsules 300mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: indobufen |
| 2 | Active comparator | Not described Receives: Drug: aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2005 (estimated)
- Study startDec 2000
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244426
- Sponsor's protocol ID
- 293-CVD-9010-004
- Other IDs
- A7651004
- Acronym
- SIFA
- Status last verified
- Dec 2018
- First submitted
- 24 Oct 2005
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- II Italian Study on Atrial Fibrillation (S.I.F.A. II): Prevention of Thromboembolic Events in Patients With Non Valvular Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT00244426
- Acronym / sponsor ID
- SIFA / 293-CVD-9010-004
- Conditions
- Atrial Fibrillation
- Keywords
- Prevention of thromboembolic events in patients with non valvular atrial fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,372 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 26 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: indobufen |
| 2 | Active comparator | Drug: aspirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic or paroxysmal non rheumatic atrial fibrillation with cardioembolic risk factors: hypertension, ischemic cardiopathy, Congestive Heart Failure, diabetes mellitus
Key exclusion criteria (4 listed)
- Clinically relevant organ disease
- creatinine clearance < 30 ml/min
- gastric or duodenal ulcer
- severe anaemia or poliglobulia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indobufenIndobufen capsules 100 and 200mg | Drug | 1 |
| aspirinAcetylsalicylic acid capsules 300mg | Drug | 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
132 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing indobufen and aspirin in people with Atrial Fibrillation, run by Pfizer at 132 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 132 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.