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A controlled, randomised, double-blind, double-dummy, parallel-group, phase III, multicenter study to evaluate efficacy and safety of the oral direct thrombin inhibitor AZD0837 compared to warfarin fo...

Update Il y a 4 ans
Reference: EUCTR2008-003698-42

A controlled, randomised, double-blind, double-dummy, parallel-group, phase III, multicenter study to evaluate efficacy and safety of the oral direct thrombin inhibitor AZD0837 compared to warfarin for the prevention of stroke and systemic embolic events (SEE) in patients with atrial fibrillation (ASSURE-AF)

Woman and Man

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Extract

The primary objective of this study is to demonstrate that AZD0837 is non-inferior to warfarin, aiming for an INR 2.0 to 3.0, target 2.5, in the prevention of the composite outcome variable of stroke and SEE.

Inclusion criteria

  • the prevention of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (AF)

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