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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: aspirin; Drug: indobufen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00244426

293-CVD-9010-004

A7651004

Details and patient eligibility

About

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.

Enrollment: 1,372 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,372 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: indobufen

2

Active Comparator group

Treatment:

Drug: aspirin