drugset / Trial / NCT00580216

Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation

NCT00580216

Phase 3 Terminated 3773 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).

Timeline

Start
2007-12
Primary completion
2010-10
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Idrabiotaparinux sodium Unknown 1.5 mg Subcutaneous
Subject Idrabiotaparinux sodium Unknown 2 mg Subcutaneous
Subject Warfarin Small molecule Oral
Background Avidin Unknown 105 mg Intravenous

Indications