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

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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

1,372 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: indobufen
2
Active Comparator group
Treatment:
Drug: aspirin

Trial contacts and locations

132

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Data sourced from clinicaltrials.gov

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