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

Pfizer1,372 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,372

Conditions

Atrial Fibrillation

Interventions

indobufenDRUG

Indobufen capsules 100 and 200mg

aspirinDRUG

Acetylsalicylic acid capsules 300mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (132)

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Lagosanto, FE, Italy

Pfizer Investigational Site

Perugia, PG, Italy

Pfizer Investigational Site

Perugia, PG, Italy

Pfizer Investigational Site

Poggibonsi, SI, Italy

Pfizer Investigational Site

Siena, SI, Italy

Pfizer Investigational Site

Busto Arsizio, VA, Italy

Pfizer Investigational Site

Peschiera del Garda, VR, Italy

Pfizer Investigational Site

Abbadia S. Salvatore (SI), Italy

Pfizer Investigational Site

Acquaviva Delle Fonti (BA), Italy

Pfizer Investigational Site

Albano Laziale, Italy

...and 122 more locations