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

Phase 3

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: indobufen; Drug: aspirin

• Registration Number: NCT00244426
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-12
• Study First Submitted: 2005-10-24
• Study First Submitted QC: 2005-10-24
• Study First Posted: 2005-10-26
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-17
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1372

Inclusion Criteria

• Chronic or paroxysmal non rheumatic atrial fibrillation with cardioembolic risk factors: hypertension, ischemic cardiopathy, Congestive Heart Failure, diabetes mellitus

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Exclusion Criteria

• Clinically relevant organ disease
• creatinine clearance < 30 ml/min
• gastric or duodenal ulcer
• severe anaemia or poliglobulia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	indobufen	-
2	aspirin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Global mortality, ischemic ictus, disabling ictus, TIA, nonfatal acute myocardial infarction, fatal and nonfatal hemorrhagic events, fatal and nonfatal embolisms.	3.5 years

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇹 Viterbo, Italy