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

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ClinicalTrials.gov Identifier: NCT00244426
Recruitment Status : Completed
First Posted : October 26, 2005
Last Update Posted : October 30, 2009
Sponsor:
Information provided by:

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
Atrial Fibrillation Drug: indobufen Drug: aspirin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
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 : December 2000
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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. [ Time Frame: 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. [ Time Frame: 3.5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244426


  Show 132 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00244426     History of Changes
Other Study ID Numbers: 293-CVD-9010-004
A7651004
First Posted: October 26, 2005    Key Record Dates
Last Update Posted: October 30, 2009
Last Verified: October 2009

Keywords provided by Pfizer:
Prevention of thromboembolic events in patients with non valvular atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Indobufen
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents